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Cardinal Health

FDA UDI

Class II (US FDA UDI)

by Cardinal Health 200, LLC

Identity

Trade Name
CARDINAL HEALTH FDA UDI
Generic Name
Urological surgical procedure kit, medicated, single-use FDA UDI
Device Name
STERILE GU CYSTO PACK FDA UDI
Model / Reference
SBAOCCYCIB FDA UDI
Description
STERILE GU CYSTO PACK FDA UDI

Identifiers

Catalog Number
SBAOCCYCIB FDA UDI
Primary DI / UDI-DI
10887488303635 FDA UDI
FDA Product Code
NWU FDA UDI
GMDN Term
Urological surgical procedure kit, medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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: Urological surgical procedure kit, medicated, single-use

Cardinal Health's STERILE GU CYSTO PACK is a single-use urological surgical procedure kit designed for sterile use in endoscopic procedures. This product offers a collection of various sterile instruments, dressings, pharmaceuticals, and necessary materials intended to support a range of urological surgical procedures.

Similar devices

Also classified as Urological surgical procedure kit, medicated, single-use.

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 9c34ed2d-1d0c-4fb7-a35b-1ea229e50c3a 34 fields · synced Oct 6, 2026