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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
Cranial port/reservoir FDA UDI
Device Name
CODMAN® HOLTER® Cerebral Catheter-Reservoir 4cm LeRoy Design FDA UDI
Model / Reference
821632 FDA UDI
Description
CODMAN® HOLTER® Cerebral Catheter-Reservoir 4cm LeRoy Design FDA UDI

Identifiers

Catalog Number
82-1632 FDA UDI
Primary DI / UDI-DI
10381780517818 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cranial port/reservoir 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 4 Centimeter FDA UDI

Category: Cranial port/reservoir

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

Similar devices

Also classified as Cranial port/reservoir.

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 7a19f690-663f-4e87-8dca-52db36e4ec00 36 fields · synced Jun 9, 2026