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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
Light Handle Cover. Flexible. 2/PK Sterile FDA UDI
Model / Reference
15160-2FG FDA UDI
Description
Light Handle Cover. Flexible. 2/PK Sterile FDA UDI

Identifiers

Catalog Number
15160-2FG FDA UDI
Primary DI / UDI-DI
20885380184120 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

No

FDA UDI

Over-the-Counter

Yes

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

No

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 80884e84-787d-4ce7-9a1f-1d8e42200b50 34 fields · synced Jun 8, 2026