Identity
- Trade Name
- STERIS FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- ICM-000-0658 STERIS Non-Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube & Holster, Sterile FDA UDI
- Model / Reference
- SSEPEN13 FDA UDI
- Description
- ICM-000-0658 STERIS Non-Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube & Holster, Sterile FDA UDI
Identifiers
- Catalog Number
- SSEPEN13 FDA UDI
- Primary DI / UDI-DI
- 00817688023685 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Steris by I.C. Medical, 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
- I.C. Medical, Inc.
Sources (1)
- FDA UDI 5905338e-8caf-4482-9ba9-d38a4a5a18b4 37 fields · synced Jun 8, 2026