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Codman Isocool

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name
CODMAN ISOCOOL FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
CODMAN ISOCOOL Bipolar Forceps Handle Flat Style, Insulated No Pin, No Rib For use with ISOCOOL Tips FDA UDI
Model / Reference
8010010HSP FDA UDI
Description
CODMAN ISOCOOL Bipolar Forceps Handle Flat Style, Insulated No Pin, No Rib For use with ISOCOOL Tips FDA UDI

Identifiers

Catalog Number
8010010HSP FDA UDI
Primary DI / UDI-DI
10886704073536 FDA UDI
510(k) Number
K083895 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Open-surgery electrosurgical handpiece/electrode, bipolar, 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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Codman Isocool by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K083895 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA UDI 43180622-51fa-4034-9162-54fa647c9696 38 fields · synced Jun 8, 2026