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Codman Holter

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name
CODMAN HOLTER FDA UDI
Generic Name
Intracerebral infusion/drainage catheter, long-term FDA UDI
Device Name
CODMAN HOLTER Ventricular Catheter 8cm FDA UDI
Model / Reference
82-1662 FDA UDI
Description
CODMAN HOLTER Ventricular Catheter 8cm FDA UDI

Identifiers

Catalog Number
821662 FDA UDI
Primary DI / UDI-DI
10886704040651 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Intracerebral infusion/drainage catheter, long-term FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Codman Holter by Cerenovus, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA UDI 2dc95f9f-c9e2-4ebf-a74e-859782f9d7d2 36 fields · synced Jun 6, 2026