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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Craniotomy kit FDA UDI
Device Name
CRANI PACK FDA UDI
Model / Reference
SNE53CNVM8 FDA UDI
Description
CRANI PACK FDA UDI

Identifiers

Catalog Number
SNE53CNVM8 FDA UDI
Primary DI / UDI-DI
10197106835579 FDA UDI
FDA Product Code
OJG FDA UDI
GMDN Term
Craniotomy kit FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
882.4525 FDA UDI
Commercial Distribution
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

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: Craniotomy kit

Cardinal Health Cardinal Health CRANI PACK is a pre-assembled, sterile collection of instruments and materials designed for craniotomy procedures. This single-use device typically includes scalpels, retractors, forceps, sutures, but does not contain pharmaceuticals.

Similar devices

Also classified as Craniotomy kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI d00467e0-27dc-4cad-a2da-ed1c633cbc26 35 fields · synced Jul 25, 2026