Identity
- Trade Name
- Carrera Loop Electrodes FDA UDI
- Generic Name
- Electrocautery system electrode FDA UDI
- Model / Reference
- CMR-2010 FDA UDI
Identifiers
- Primary DI / UDI-DI
- GYNXCMR20101 FDA UDI
- 510(k) Number
- K982739 FDA UDI
- FDA Product Code
- HGI FDA UDI
- GMDN Term
- Electrocautery system electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4120 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
No
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
No
FDA UDI
Category: Electrocautery system electrode
Carrera Loop Electrodes by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K982739 also covers:
- Ball Electrodes — GYNEX CORPORATION
- Ball Electrodes — GYNEX CORPORATION
- Carrera Ball Electrodes — GYNEX CORPORATION
- Carrera Ball Electrodes — GYNEX CORPORATION
- Carrera Loop ELectrodes — GYNEX CORPORATION
- Carrera Loop Electrode — GYNEX CORPORATION
- Carrera Loop Electrode — GYNEX CORPORATION
- Carrera Loop Electrodes — GYNEX CORPORATION
- Carrera Loop Electrodes — GYNEX CORPORATION
- Carrera Loop Electrodes — GYNEX CORPORATION
- Carrera Loop Electrodes — GYNEX CORPORATION
- Carrera Loop Electrodes — GYNEX CORPORATION
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
- Gynex Corporation
Sources (1)
- FDA UDI 251bcb7a-3b4a-48be-bb3a-7c956ecf4a4a 33 fields · synced Jun 8, 2026