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Steris

FDA UDI

Class II (US FDA UDI)

by I.C. Medical, Inc.

Identity

Trade Name
STERIS FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
ICM-000-0620 STERIS Non-Telescopic ESU Pencil, Non-Stick Blade, 10 Foot Tube & Holster, Non-Sterile, Bulk FDA UDI
Model / Reference
SSEPEN08 FDA UDI
Description
ICM-000-0620 STERIS Non-Telescopic ESU Pencil, Non-Stick Blade, 10 Foot Tube & Holster, Non-Sterile, Bulk FDA UDI

Identifiers

Catalog Number
SSEPEN08 FDA UDI
Primary DI / UDI-DI
00817688023173 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

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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
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

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Manufacturer

Manufacturer
I.C. Medical, Inc.

Sources (1)

  • FDA UDI c7851bdd-9559-44f4-bbd9-86d243793e5c 37 fields · synced May 30, 2026