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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
KIT, BLO CYSTO FDA UDI
Model / Reference
PUCGCYBL7 FDA UDI
Description
KIT, BLO CYSTO FDA UDI

Identifiers

Catalog Number
PUCGCYBL7 FDA UDI
Primary DI / UDI-DI
10197106119167 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 Urological Surgical Procedure Kit (UCS PK) is a single-use, sterile device designed to facilitate urological surgical procedures. This kit contains a collection of various sterile instruments, dressings, and pharmaceuticals necessary for the procedure. The UCS PK is exempt from PM exemption due to its sterilization requirements.

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 10d3b40f-8061-4270-9215-f4b9d94f15c8 34 fields · synced Jul 21, 2026