Identity
- Trade Name
- Megadyne FDA UDI
- Generic Name
- Electrosurgical cable adaptor FDA UDI
- Device Name
- Monopolar Adapter, For Mega Power Generator FDA UDI
- Model / Reference
- 96007 FDA UDI
- Description
- Monopolar Adapter, For Mega Power Generator FDA UDI
Identifiers
- Catalog Number
- 96007 FDA UDI
- Primary DI / UDI-DI
- 10614559104415 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrosurgical cable adaptor 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
Yes
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
Category: Electrosurgical cable adaptor
Megadyne by Megadyne Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrosurgical cable adaptor.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- Medichoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- VESALIUS bipolar connector for scissors — TELEA ELECTRONIC ENGEENERING SRL · Class II
- ERBE — Erbe Elektromedizin GmbH · Class II
- Valleylab — Covidien LP · Class II
- COOLIEF* — Avanos Medical, Inc. · Class II
- Nimbus Probe Adapter Cable — Stratus Medical LLC · Class II
Cleared under the same submission
K050579 also covers:
K111262 also covers:
- CONMED — Conmed Corporation
- Boston Scientific — Olsen Medical
- Boston Scientific — Olsen Medical
- Boston Scientific — Olsen Medical
- Boston Scientific — Olsen Medical
- Boston Scientific — Olsen Medical
- Boston Scientific — Olsen Medical
- Boston Scientific — Olsen Medical
- ConMed — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
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
- Megadyne Medical Products, Inc.
Sources (1)
- FDA UDI f923b423-7dda-48f5-b1b1-9934fc75d7ad 37 fields · synced Jun 9, 2026