Identity
- Trade Name
- PenEvac1 FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk FDA UDI
- Model / Reference
- ICM-000-0590 FDA UDI
- Description
- PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk FDA UDI
Identifiers
- Catalog Number
- ICM-000-0590 FDA UDI
- Primary DI / UDI-DI
- 00817688022886 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PenEvac1 by I.C. Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- I.C. Medical, Inc.
Sources (1)
- FDA UDI c8bd4190-9ed9-4997-817b-d764d87845bd 36 fields · synced Jun 1, 2026