Identity
- Trade Name
- AVANOS FDA UDI
- Generic Name
- Electrosurgical cable adaptor FDA UDI
- Device Name
- Bipolar Adapter FDA UDI
- Model / Reference
- PMA-BP FDA UDI
- Description
- Bipolar Adapter FDA UDI
Identifiers
- Catalog Number
- PMA-BP FDA UDI
- Primary DI / UDI-DI
- 00193493985951 FDA UDI
- 510(k) Number
- K002389 FDA UDI
- FDA Product Code
- GXI FDA UDI
- GMDN Term
- Electrosurgical cable adaptor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4725 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical cable adaptor
Avanos by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K002389 also covers:
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
- AVANOS — Avanos Medical, Inc.
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
- Avanos Medical, Inc.
Sources (1)
- FDA UDI ce8766c4-af0f-4078-8dca-27bc2fe9b5c5 36 fields · synced Jun 9, 2026