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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
Medical equipment handle cover, single-use FDA UDI
Device Name
Cardinal Health Flexible Light Handle Cover Green FDA UDI
Model / Reference
5128-FG FDA UDI
Description
Cardinal Health Flexible Light Handle Cover Green FDA UDI

Identifiers

Catalog Number
5128-FG FDA UDI
Primary DI / UDI-DI
10885380121937 FDA UDI
FDA Product Code
FTA FDA UDI
GMDN Term
Medical equipment handle cover, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4580 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

Category: Medical equipment handle cover, single-use

Cardinal Health by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment handle cover, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 9c26058d-fe37-49b4-9d18-bc64e7c2b8a2 34 fields · synced Jun 8, 2026