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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
Nephroscopic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
GU KIDNEY PACK FDA UDI
Model / Reference
SOT11KP102 FDA UDI
Description
GU KIDNEY PACK FDA UDI

Identifiers

Catalog Number
SOT11KP102 FDA UDI
Primary DI / UDI-DI
10195594251529 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
Nephroscopic surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 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: Nephroscopic surgical procedure kit, non-medicated, single-use

A comprehensive medical device directory for the General Surgery Tray Open (General Surgery tray open) device, including its features, compliance information, and FAQs.

Similar devices

Also classified as Nephroscopic surgical procedure kit, non-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 93d8658b-144e-4a2f-8df2-6056253cb28b 35 fields · synced Oct 6, 2026