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Codman® Holter®

FDA UDI

Class II (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
CODMAN® HOLTER® FDA UDI
Generic Name
Atrial cerebrospinal fluid catheter FDA UDI
Device Name
CODMAN® HOLTER® Atrial Catheter Type "A" FDA UDI
Model / Reference
821670 FDA UDI
Description
CODMAN® HOLTER® Atrial Catheter Type "A" FDA UDI

Identifiers

Catalog Number
82-1670 FDA UDI
Primary DI / UDI-DI
10381780517979 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Atrial cerebrospinal fluid catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Atrial cerebrospinal fluid catheter

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

Similar devices

Also classified as Atrial cerebrospinal fluid catheter.

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 47a5fa8e-825f-40e0-a8dc-f33316c66b74 35 fields · synced Jun 9, 2026