Identity
- Trade Name
- GEM COUPLER Double Ended Vessel Measuring Gauge FDA UDI
- Generic Name
- Vascular anastomosis coupling sizer FDA UDI
- Device Name
- A reusable instrument used to estimate the outside diameter of a blood vessel (1mm - 4mm). FDA UDI
- Model / Reference
- GEM2749 FDA UDI
- Description
- A reusable instrument used to estimate the outside diameter of a blood vessel (1mm - 4mm). FDA UDI
Identifiers
- Catalog Number
- 519304002010 FDA UDI
- Primary DI / UDI-DI
- 00844735002843 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Vascular anastomosis coupling sizer 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Vascular anastomosis coupling sizer
GEM COUPLER Double Ended Vessel Measuring Gauge 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 a081ddd9-1ad6-4df1-bd18-def01ce1e7a6 36 fields · synced May 31, 2026