Codman®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: CODMAN® FDA UDI
Generic Name: Intracranial pressure monitor FDA UDI
Device Name: CODMAN® Peel-Away Catheter Introducer 9Fr. FDA UDI
Model / Reference: 831323 FDA UDI
Description: CODMAN® Peel-Away Catheter Introducer 9Fr. FDA UDI

Identifiers

Catalog Number: 83-1323 FDA UDI
Primary DI / UDI-DI: 10381780521396 FDA UDI
510(k) Number: K883607 FDA UDI
FDA Product Code: GYK FDA UDI
GMDN Term: Intracranial pressure monitor FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 882.4545 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 9 French FDA UDI

Category: Intracranial pressure monitor

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

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Cleared under the same submission

K883607 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI 1068b74e-39f7-4b63-8a24-d9a2ce4335d1 37 fields · synced Jun 9, 2026