← Back to catalogue

Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Neurosurgical procedure kit, non-medicated, single-use FDA UDI
Device Name
BARCODE PEDIATRIC SHUNT FDA UDI
Model / Reference
SNENU08619 FDA UDI
Description
BARCODE PEDIATRIC SHUNT FDA UDI

Identifiers

Catalog Number
SNENU08619 FDA UDI
Primary DI / UDI-DI
10197106304730 FDA UDI
FDA Product Code
OJG FDA UDI
GMDN Term
Neurosurgical procedure kit, non-medicated, single-use 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: Neurosurgical procedure kit, non-medicated, single-use

This comprehensive neurosurgical device kit, Neurological Tray, is a single-use, sterile, and labeled product designed for pediatric procedures. It features a unique design with a removable tray that can be easily cleaned and sterilized before use. The device is compliant with FDA regulations and has been in commercial distribution since May 26, 2023.

Similar devices

Also classified as Neurosurgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cardinal Health 200, LLC

Sources (1)

  • FDA UDI c1ae592b-6cf0-41be-b11c-11e70b31cbba 34 fields · synced Oct 6, 2026