Identity
- Trade Name
- Megadyne EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- LLETZ Loop Electrode, 10mm wide x 7mm deep, 11.8 cm shaft, orange FDA UDI
- Model / Reference
- 0410 EUDAMEDFDA UDI
- Description
- LLETZ Loop Electrode, 10mm wide x 7mm deep, 11.8 cm shaft, orange FDA UDI
Identifiers
- Catalog Number
- 0410 FDA UDI
- Primary DI / UDI-DI
- D-USMF000017046000011RQ EUDAMED10614559101148 FDA UDI
- Basic UDI-DI
- B-USMF000017046000011RQ EUDAMED
- 510(k) Number
- K925478 FDA UDI
- FDA Product Code
- HGI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4120 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Megadyne by Megadyne Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (2)
- FDA UDI fc5066d2-55a2-4792-9482-55b6d8d8143b 37 fields · synced Oct 6, 2026
- EUDAMED d873ba7c-eaf4-43aa-8d86-ae4d87be3a5a 61 fields · synced Jul 13, 2026