Identity
- Trade Name
- GEM BIOVER Microvascular Clamp FDA UDI
- Generic Name
- Surgical bulldog clamp, single-use FDA UDI
- Device Name
- Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins FDA UDI
- Model / Reference
- TKSV1 FDA UDI
- Description
- Microvascular clamps are used for end-to-end anastomotic procedures for arteries and veins FDA UDI
Identifiers
- Catalog Number
- TKSV1 FDA UDI
- Primary DI / UDI-DI
- 00844735006247 FDA UDI
- FDA Product Code
- DXC FDA UDI
- GMDN Term
- Surgical bulldog clamp, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Category: Surgical bulldog clamp, single-use
GEM BIOVER Microvascular Clamp by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical bulldog clamp, single-use.
- KİNG — İNVAMED SAĞLIK İLAÇ SANAYİ VE TİCARET A.Ş. · Class III
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- Wexler Surgical, Inc. — Wexler Surgical, Inc. · Class I
- Scanlan® VASCU-STATT® Plus aprox s-use bulldog clamp w/Gentle-Jaw™ surface — SCANLAN INTERNATIONAL INC · Class I
- BM-BID-I30C — BrosMed Medical Co., Ltd. · Class I
- Sterile Vascular Silicone Ties — BATRIK MEDICAL MANUFACTURING INC. · Class IIa
- Scanlan® VASCU-STATT® approximator single-use bulldog clamp — SCANLAN INTERNATIONAL INC · Class I
- BM-BID-I30P — BrosMed Medical Co., Ltd. · Class I
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 346098a3-2653-4a70-b648-76744f42f89e 35 fields · synced May 30, 2026