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® Disposable Catheter Passer FDA UDI
Model / Reference: 821516 FDA UDI
Description: CODMAN® Disposable Catheter Passer FDA UDI

Identifiers

Catalog Number: 82-1516 FDA UDI
Primary DI / UDI-DI: 10381780515494 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 55 Centimeter 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.

AVANOS — Avanos Medical, Inc. · Class II
CORTRAK* 2 Enteral Access System — Avanos Medical, Inc. · Class II
AESCULAP — AESCULAP, INC. · Class I
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

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

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

Manufacturer

Manufacturer: Integra LifeSciences Production Corporation

Sources (1)

FDA UDI 46d084c3-64f1-4ab3-9c39-9803b6047895 36 fields · synced Jun 9, 2026