Identity
- Trade Name
- Megadyne FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Device Name
- E-Z Pen 12 Use Electrosurgical Pencil Button Switch 10 foot (3 m) cord Holster FDA UDI
- Model / Reference
- 3035H FDA UDI
- Description
- E-Z Pen 12 Use Electrosurgical Pencil Button Switch 10 foot (3 m) cord Holster FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10614559102541 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Megadyne by Megadyne Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 (1)
- FDA UDI fe54e857-d9f6-42c7-a1b9-cddaff3daa05 36 fields · synced Jun 9, 2026