Identity
- Trade Name
- MEGADYNE EUDAMEDFDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- LLETZ Loop Electrode, 15mm wide x 12mm deep, 11.8 cm shaft, green FDA UDI
- Model / Reference
- 0460 EUDAMEDFDA UDI
- Description
- LLETZ Loop Electrode, 15mm wide x 12mm deep, 11.8 cm shaft, green FDA UDI
Identifiers
- Catalog Number
- 0460 FDA UDI
- Primary DI / UDI-DI
- D-USMF000017046000016S2 EUDAMED10614559101193 FDA UDI
- Basic UDI-DI
- B-USMF000017046000016S2 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Open-surgery electrosurgical electrode, monopolar, single-use
Megadyne by Megadyne Medical Products, Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000017046000016S2 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Megadyne Medical Products, Inc.
- EUDAMED SRN
- US-MF-000017046
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 572d5fb5-2164-45bb-bc77-213a93e67769 61 fields · synced Jun 9, 2026
- FDA UDI 3135d05f-301b-4165-80a4-d2c3cdcbd4da 37 fields · synced May 30, 2026