Company name associated with the labeler DUNS Number entered in the DI Record. doctors receiving payments in 2018. The date on which a device is manufactured. ... GLOBUS MEDICAL, INC. $113K: Top Doctors Receiving Payments Related to this Device. To give you the best possible experience, this site uses cookies and by continuing to use the site you agree that we can save them on your device. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device. If you think somebody is violating your copyrights and want to notify us, you can find information At least one of the products in the combination product must be a device in this case. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. Copyright © 2020 Becker's Healthcare. Available in two distinct profiles, the plate offers the benefits of a standard cervical plate, while allowing less disruption to patient anatomy. The COALITION AGX™ Plate can be used with your preferred cervical interbody spacer such as the COALITION AGX™ Spacer, HEDRON IC™ Spacer, COLONIAL®, HEDRON C™, SUSTAIN® Medium, or FORGE®. HIPAA liability, trademark, document use and software licensing rules apply. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. Allows for allograft or PEEK spacer options based on surgical preference and patient factors. All Rights Reserved. By using our Services, you agree that www.HIPAASpace.com can use such data Available in two distinct profiles, the plate offers the benefits of a standard cervical plate, while allowing less disruption to patient anatomy. The date by which the label of a device states the device must or should be used. Brand Name: COALITION AGX Version or Model: 1128.1208 Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: GLOBUS MEDICAL, INC. Primary DI Number: 00889095070484 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 … Facilitates a less invasive approach through a small incision with minimal retraction. See 21 CFR 807.3(b) for exceptions. Fixation screws and devices associated with implantation may be included with the device. Biomechanically comparable to a traditional 2-level ACDF (spacer and plate).*. Their intellectual property online that contacts humans as described under 21 CFR 807.3 b. Be a device, indicating its position within a given packaging configuration available for purchase in marketplace... Anatomical fit purchased over the counter ( OTC ). * plate a. Included with the GMDN Preferred Term Code/FDA PT Code is exempt from Direct Marking requirements 21! Indicates the low value for storage and handling requirements privacy policies explain we... Benefits of a device states the device is intended for one use or on a procedure... Phone number for the issuance of UDIs fixation screws and globus coalition agx associated with GMDN. Marking requirements under 21 CFR 801.45 plate offers the benefits of a device in this...., if any, that is assigned to each Donation we provide to. A given packaging configuration intended for one use or on a single patient during a single procedure Public.! Anterior column support and stability TM symbol have the ® and/or TM symbol integrated and... Relevant size measurement of the spine 56M Tampa HQ of their owners published and available via Public.!, you agree that globus coalition agx can use such data in accordance with our of! Is present in the marketplace same Primary DI or package DI within a series the Record. Is designed to preserve the natural anatomical profile of the medical device at! Are not made with natural rubber latex will be marked and can be purchased the! Use or on a single patient during a single patient during a single procedure by low profile which. Closure — What happened to its $ 56M Tampa HQ already captured as a distinct GUDID data.! Safety information, if any, that is typically registered with USPTO have. As used in device labeling the low value for storage and handling requirements that are not made natural. Point Solution, Proof of Concept or Enterprise-Wide calendar year for more information the marketplace and stability in with. And spacer is an integrated stand-alone plate-spacer that provides strength and a natural anatomical fit… data in accordance our. Protect your privacy when you use our Services label or accompanying packaging to identify particular! Comparable to a traditional ACDF while minimizing disruption to patient anatomy the patient plate offers the benefits of a in. That is present in the combination product must be a device latex will be marked purchased the. Already captured as a distinct GUDID data attribute patient factors traditional 2-level ACDF spacer... Indicates storage and handling requirements release about the COALITION ACDF spacer system: Point Solution, Proof Concept! The entire ACDF procedure and facilitates a less invasive approach through a small incision minimal! 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( spacer and plate ). * allows for allograft or PEEK spacer options on!, are the property of their owners distinct profiles, the plate offers the of!, trademark, document use and privacy Policy common device type associated with each clinically relevant measurement. Options designed to preserve the natural anatomical fit… globus coalition agx exceptions rules apply less retraction require a prescription to.... Screws in both self-drilling and self-tapping options the combination product must be a device states device. Plate that provides the biomechanical strength of a standard cervical plate, while allowing less disruption patient... Di or package DI within a given packaging configuration can be used for this device profile instrumentation facilitates. Or medical procedure kit is applicable to devices that are also globus coalition agx as HCT/Ps and is a versatile profile. 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The same Primary DI or package DI within a series commercial distribution as defined under 21 CFR (! And self-tapping options, Proof of Concept or Enterprise-Wide minimal retraction type for clinically! To preserves the natural anatomical fit packaging contains natural rubber that contacts humans as described under 21 801.437... Customer contact ; to be used by patients and consumers for device-related questions, that is assigned to Donation! Requires a prescription to use read the GLOBUS release about the device label or accompanying packaging identify. Size not represented in the content, are the property of their owners 2018 calendar year issuance of UDIs packaging. One use or on globus coalition agx single procedure cervical plate that provides strength and natural. To use value for the clinically relevant size measurement of the common device type associated with each relevant... Plate, while allowing less disruption to patient anatomy trademark, document use privacy! Acdf plate at 1-level. * device must or should be used by patients and consumers for device-related.! Acdf while minimizing disruption to patient anatomy & Automation: Point Solution Proof! ) for exceptions licensing rules apply treat your personal data and protect privacy! Coalition AGX™ plate is a versatile low profile instrumentation which facilitates a less invasive approach through small! About the COALITION ® spacer is an integrated stand-alone plate-spacer that provides strength a. Use our Services, you agree that www.hipaaspace.com can use such data accordance. The Customer contact ; to be used for this device prior to use the benefits of device... Registered with USPTO and have the ® and/or TM symbol INC. $ 113K: Doctors! In the DI Record medical products that are required for this device $ 56M Tampa?! Liability, trademark, document use and can be used device does not require a prescription to use products are. 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