Identity
- Trade Name
- MEGADYNE EUDAMEDFDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, reusable FDA UDI
- Device Name
- Electrosurgical Laparoscopic Electrode with Indicator, Long, 38 cm., Reusable, for use with hand control pencil and MEGAtips FDA UDI
- Model / Reference
- 0695 EUDAMEDFDA UDI
- Description
- Electrosurgical Laparoscopic Electrode with Indicator, Long, 38 cm., Reusable, for use with hand control pencil and MEGAtips FDA UDI
Identifiers
- Catalog Number
- 0695 FDA UDI
- Primary DI / UDI-DI
- D-USMF000017046000005RV EUDAMED10614559101254 FDA UDI
- Basic UDI-DI
- B-USMF000017046000005RV 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, reusable 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
No
Single Use
No
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
No
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
Similar devices
Also classified as Open-surgery electrosurgical handpiece/electrode, monopolar, single-use.
- PlasmaBlade™ — MEDTRONIC NAVIGATION, INC. · Class II
- Victan — Jiangsu Haize Medical Scientific Development Co., Ltd. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Bovie — SYMMETRY SURGICAL INC. · Class II
- Disposable Bipolar Suction Coagulator 7 1/2in. (19cm) 8 Fr — KIRWAN SURGICAL PRODUCTS LLC · Class IIb
- Valleylab — Covidien LP · Class II
- A&E Medical / Disposable Suction Coagulator — A & E MEDICAL CORPORATION · Class II
- PlasmaBladeTM — MEDTRONIC NAVIGATION, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-USMF000017046000005RV | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megadyne Medical Products, Inc.
- EUDAMED SRN
- US-MF-000017046
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (2)
- EUDAMED 95c0d7b1-9b56-4a30-84dd-9c0f402be1c1 61 fields · synced Jul 21, 2026
- FDA UDI f3922b21-31dc-480b-99d0-f5fe4b25e345 37 fields · synced May 30, 2026