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 Split Stem, 33 cm., Single-Use, for use with foot control pedal FDA UDI
- Model / Reference
- 0100S EUDAMEDFDA UDI
- Description
- E-Z Clean, PTFE Coated, Electrosurgical Laparoscopic Electrode, L-Wire Split Stem, 33 cm., Single-Use, for use with foot control pedal FDA UDI
Identifiers
- Catalog Number
- 0100S FDA UDI
- Primary DI / UDI-DI
- D-USMF000017046000069SP EUDAMED10614559100677 FDA UDI
- Basic UDI-DI
- B-USMF000017046000069SP EUDAMED
- 510(k) Number
- K913281 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010302 LAPAR AND THORACOSCOPIC ELECTROSURGERY ELECTRODES, 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
- 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
K913281 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 46489f09-c3d0-4d98-955b-0e0726551d87 37 fields · synced Oct 6, 2026
- EUDAMED 54d4aa1d-dc8c-48ec-836d-577a4b16a314 61 fields · synced Jul 9, 2026