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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, non-medicated, single-use FDA UDI
Device Name
STERILE ENDOVASCULAR AAA PACK FDA UDI
Model / Reference
SCV11EORJQ FDA UDI
Description
STERILE ENDOVASCULAR AAA PACK FDA UDI

Identifiers

Catalog Number
SCV11EORJQ FDA UDI
Primary DI / UDI-DI
10887488377896 FDA UDI
FDA Product Code
NWU FDA UDI
GMDN Term
Urological surgical procedure kit, non-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, non-medicated, single-use

Cardinal Health's Endoscope Introducer Kit is a single-use, sterile endovascular AAA pack designed for gastroenterology and urology procedures. This kit includes various instruments and materials intended to be used during surgical or endoscopic procedures, without containing pharmaceuticals.

Similar devices

Also classified as Urological 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 67442a0a-20bb-4bcb-b00d-b0778aaa2319 35 fields · synced Oct 6, 2026