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Codman

FDA UDI

Class II (US FDA UDI)

by Cerenovus, Inc.

Identity

Trade Name
CODMAN FDA UDI
Generic Name
Intracerebral catheter cranial-fixation kit FDA UDI
Device Name
CODMAN Cranial Access Kit Without Drugs FDA UDI
Model / Reference
82-6616 FDA UDI
Description
CODMAN Cranial Access Kit Without Drugs FDA UDI

Identifiers

Catalog Number
826616 FDA UDI
Primary DI / UDI-DI
20886704042287 FDA UDI
510(k) Number
K914479 FDA UDI
FDA Product Code
GWM FDA UDI
GMDN Term
Intracerebral catheter cranial-fixation kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1620 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

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

Cleared under the same submission

K914479 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cerenovus, Inc.

Sources (1)

  • FDA UDI ce3417cf-d809-4b1f-bbb3-d738e5ac33a9 38 fields · synced May 30, 2026