Identity
- Trade Name
- CODMAN HARDY FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- CODMAN HARDY Bayonet Bipolar Forceps Insulated Non Stick Mirror Finish 0.7mm Tip 213mm FDA UDI
- Model / Reference
- 80-3060 FDA UDI
- Description
- CODMAN HARDY Bayonet Bipolar Forceps Insulated Non Stick Mirror Finish 0.7mm Tip 213mm FDA UDI
Identifiers
- Catalog Number
- 803060 FDA UDI
- Primary DI / UDI-DI
- 10886704039570 FDA UDI
- 510(k) Number
- K963499 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
- Not 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Codman Hardy by Cerenovus, 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
- Cerenovus, Inc.
Sources (1)
- FDA UDI b4f98c14-7ddd-484d-a9f7-4719bb4d45e1 38 fields · synced May 31, 2026