Identity
- Trade Name
- GEM VESSEL EVERTER FDA UDI
- Generic Name
- Vascular anastomosis coupling kit, single-use FDA UDI
- Device Name
- The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device to press vessel tissue onto the GEM Flow COUPLER/COUPLER rings, and to measure the vessel, if needed. FDA UDI
- Model / Reference
- GEM2742 FDA UDI
- Description
- The VESSEL EVERTER System is used with the GEM COUPLER and Flow COUPLER Device to press vessel tissue onto the GEM Flow COUPLER/COUPLER rings, and to measure the vessel, if needed. FDA UDI
Identifiers
- Catalog Number
- 519600001061 FDA UDI
- Primary DI / UDI-DI
- 00844735006179 FDA UDI
- 510(k) Number
- K190499 FDA UDI
- FDA Product Code
- MVR FDA UDI
- GMDN Term
- Vascular anastomosis coupling kit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Gem Vessel Everter by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Synovis Micro Companies Alliance, Inc
Sources (1)
- FDA UDI 9eaac3f0-9774-4ecc-8322-3887ce651b30 38 fields · synced May 30, 2026