Identity
- Trade Name
- Black & Black Surgical FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT TIP (1 PAIR) FDA UDI
- Model / Reference
- B65227 FDA UDI
- Description
- B&B E-P ELECTROSURGICAL DISSECTOR; 14.5''(36.5CM), CURVED ON STRAIGHT, STRAIGHT TIP (1 PAIR) FDA UDI
Identifiers
- Catalog Number
- B65227 FDA UDI
- Primary DI / UDI-DI
- 00840329829179 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, 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
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
Yes
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
Category: Endoscopic electrosurgical electrode, monopolar, reusable
Black & Black Surgical by Black & Black Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical electrode, monopolar, reusable.
- Snowden-Pencer — STERIS CORPORATION · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- Snowden-Pencer — STERIS CORPORATION · Class II
- Gimmi — Gimmi GmbH · Class II
- Bovie — BOVIE MEDICAL CORPORATION · Class II
- AEM® Suction Irrigation Electrode J-Hook, 35cm — ENCISION, INC. · Class II
- C35-20mm Fenestrated insert L=330mm D=3, 5mm — Medica Corp. · Class II
- Snowden-Pencer — STERIS CORPORATION · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Black & Black Surgical, Inc.
Sources (1)
- FDA UDI 5822e68b-8391-439a-a4e9-f5d92cd2d356 35 fields · synced Jun 8, 2026