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Codman®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
CODMAN® FDA UDI
Generic Name
Craniotomy kit FDA UDI
Device Name
CODMAN® Disposable ICP Kit, Plastic, Pediatric FDA UDI
Model / Reference
801197 FDA UDI
Description
CODMAN® Disposable ICP Kit, Plastic, Pediatric FDA UDI

Identifiers

Catalog Number
80-1197 FDA UDI
Primary DI / UDI-DI
10381780514879 FDA UDI
510(k) Number
K853770 FDA UDI
FDA Product Code
GWM FDA UDI
GMDN Term
Craniotomy kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1620 FDA UDI
Commercial Distribution
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

Yes

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

Category: Craniotomy kit

Codman® by Integra LifeSciences Production Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Craniotomy kit.

Cleared under the same submission

K853770 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 6010546f-e42f-46f6-b8fb-57a47cd74b77 37 fields · synced Jun 9, 2026