Identity
- Trade Name
- GEM BiPolar Adson Forceps FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes. FDA UDI
- Model / Reference
- GEM4100A-NS FDA UDI
- Description
- Reusable bipolar forceps designed to function as active electrodes or as accessories to active electrodes. FDA UDI
Identifiers
- Catalog Number
- 521441000010 FDA UDI
- Primary DI / UDI-DI
- 00844735006100 FDA UDI
- 510(k) Number
- K130669 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
GEM BiPolar Adson Forceps by Synovis Micro Companies Alliance, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, bipolar, reusable.
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- STINGRAY SURGICAL PRODUCTS — STINGRAY SURGICAL PRODUCTS L.L.C. · Class II
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Cleared under the same submission
K130669 also covers:
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
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 fa635d93-2722-452a-b186-bcc48ea1eb72 37 fields · synced May 30, 2026