Identity
- Trade Name
- Megadyne FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- LLETZ Loop Electrode, 10mm wide x 10mm deep, 11.8 cm shaft, yellow FDA UDI
- Model / Reference
- 0450 FDA UDI
- Description
- LLETZ Loop Electrode, 10mm wide x 10mm deep, 11.8 cm shaft, yellow FDA UDI
Identifiers
- Catalog Number
- 0450 FDA UDI
- Primary DI / UDI-DI
- 10614559101186 FDA UDI
- 510(k) Number
- K925478 FDA UDI
- FDA Product Code
- HGI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Megadyne by Megadyne Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K925478 also covers:
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
- Megadyne Medical Products, Inc.
Sources (1)
- FDA UDI 404c5722-6c0b-4c4d-9038-0d13423fe201 37 fields · synced Jun 9, 2026