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Codman Isocool Aht

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name
CODMAN ISOCOOL AHT FDA UDI
Generic Name
Open-surgery electrosurgical handpiece/electrode, bipolar, reusable FDA UDI
Device Name
CODMAN ISOCOOL AHT Bipolar Forceps Tips 8 1/2 Inches (22cm) Total Length 0.25mm Tip Diameter 3 1/2 Inches (8.9cm) Working Length Low Profile TIP STYLE FDA UDI
Model / Reference
8135025S FDA UDI
Description
CODMAN ISOCOOL AHT Bipolar Forceps Tips 8 1/2 Inches (22cm) Total Length 0.25mm Tip Diameter 3 1/2 Inches (8.9cm) Working Length Low Profile TIP STYLE FDA UDI

Identifiers

Catalog Number
8135025S FDA UDI
Primary DI / UDI-DI
10886704040118 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

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

Codman Isocool Aht 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 a0e3cbc2-8874-4e99-8b86-0f37601f715b 37 fields · synced Jun 1, 2026