Identity
- Trade Name
- Oph.Forceps FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
- Device Name
- Cautery Pen, Reusable, 23 Gauge, Tapered FDA UDI
- Model / Reference
- 08-13210 FDA UDI
- Description
- Cautery Pen, Reusable, 23 Gauge, Tapered FDA UDI
Identifiers
- Catalog Number
- 08-13210 FDA UDI
- Primary DI / UDI-DI
- 00841668120101 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 23 Gauge FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, bipolar, reusable
Oph.Forceps by Katena Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Katena Products, Inc.
Sources (1)
- FDA UDI ba54e263-d6c8-4bd0-b078-dde7327e196b 36 fields · synced Jun 12, 2026