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Cardinal Health

FDA UDI

Class I (US FDA UDI)

by Microtek Medical LLC

Identity

Trade Name
Cardinal Health FDA UDI
Generic Name
Intraoperative procedure bag FDA UDI
Device Name
ISOLATION BAG 18X18.5IN CARDINAL FDA UDI
Model / Reference
Organ Bag FDA UDI
Description
ISOLATION BAG 18X18.5IN CARDINAL FDA UDI

Identifiers

Catalog Number
29-10039 FDA UDI
Primary DI / UDI-DI
00748426123568 FDA UDI
FDA Product Code
KGY FDA UDI
GMDN Term
Intraoperative procedure bag FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4100 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

No

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

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Intraoperative procedure bag

Cardinal Health by Microtek Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative procedure bag.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Microtek Medical LLC

Sources (1)

  • FDA UDI 765ff6b0-0d00-421d-9a8e-dffc891ef19c 35 fields · synced Jun 8, 2026