← Back to catalogue

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 10 1/2 Inches (26.7cm) Total Length 1mm Tip diameter 5 1/2 Inches (14cm) Working Length TIP STYLE Low Profile FDA UDI
Model / Reference
8155100S FDA UDI
Description
CODMAN ISOCOOL AHT Bipolar Forceps Tips 10 1/2 Inches (26.7cm) Total Length 1mm Tip diameter 5 1/2 Inches (14cm) Working Length TIP STYLE Low Profile FDA UDI

Identifiers

Catalog Number
8155100S FDA UDI
Primary DI / UDI-DI
10886704040217 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA UDI b2f080d6-5331-4faf-8c96-44dba3d88096 37 fields · synced May 31, 2026