Identity
- Trade Name
- MEGADYNE EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire Modified, Single-Use, Tip Only, for use with Reusable Indicator Shaft FDA UDI
- Model / Reference
- 0600M EUDAMEDFDA UDI
- Description
- E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire Modified, Single-Use, Tip Only, for use with Reusable Indicator Shaft FDA UDI
Identifiers
- Catalog Number
- 0600M FDA UDI
- Primary DI / UDI-DI
- D-USMF000017046000130RZ EUDAMED10614559101063 FDA UDI
- Basic UDI-DI
- B-USMF000017046000130RZ EUDAMED
- 510(k) Number
- K943055 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010501 OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- 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 handpiece/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-USMF000017046000130RZ | 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 a1e719ec-ae15-4481-a685-c384665e8cc3 61 fields · synced Jun 9, 2026
- FDA UDI 16babb31-0326-467e-b215-28b381ec88ff 37 fields · synced May 30, 2026