Identity
- Trade Name
- GEM COUPLER Microvascular Anastomotic Instrument FDA UDI
- Generic Name
- Vascular anastomosis coupling approximator FDA UDI
- Device Name
- A reusable Instrument designed to hold the GEM COUPLER device and approximate the GEM COUPLER rings during vessel anastomosis FDA UDI
- Model / Reference
- GEM2740 FDA UDI
- Description
- A reusable Instrument designed to hold the GEM COUPLER device and approximate the GEM COUPLER rings during vessel anastomosis FDA UDI
Identifiers
- Catalog Number
- 519303002010 FDA UDI
- Primary DI / UDI-DI
- 00844735005233 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Vascular anastomosis coupling approximator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular anastomosis coupling approximator
GEM COUPLER Microvascular Anastomotic Instrument by Synovis Micro Companies Alliance, Inc — Class I — FDA UDI — listed in FDA GUDID
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI a1b816b2-f50a-4d44-a995-5eb14ba01141 36 fields · synced May 30, 2026