Codman®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name: CODMAN® FDA UDI
Generic Name: Subcutaneous tunneller, single-use FDA UDI
Device Name: CODMAN® Peel-Away Catheter Introducer 12.5FR. FDA UDI
Model / Reference: 831325 FDA UDI
Description: CODMAN® Peel-Away Catheter Introducer 12.5FR. FDA UDI

Identifiers

Catalog Number: 83-1325 FDA UDI
Primary DI / UDI-DI: 10381780521402 FDA UDI
510(k) Number: K883607 FDA UDI
FDA Product Code: GYK FDA UDI
GMDN Term: Subcutaneous tunneller, single-use 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 — 12.5 French FDA UDI

Category: Subcutaneous tunneller, single-use

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

Similar devices

Also classified as Subcutaneous tunneller, single-use.

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PMT® CORPORATION — Pmt Corp. · Class I
Halyard — Avanos Medical, Inc. · Class II
AVANOS — Avanos Medical, Inc. · Class II
Halyard — Avanos Medical, Inc. · Class II
Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III

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 dfd05920-6a35-4f9e-8321-20349a236b2a 37 fields · synced Jun 9, 2026