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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
Topical coupling gel, sterile FDA UDI
Device Name
ULTRASOUND GEL 20GM STL FDA UDI
Model / Reference
USG20-ST FDA UDI
Description
ULTRASOUND GEL 20GM STL FDA UDI

Identifiers

Catalog Number
USG20-ST FDA UDI
Primary DI / UDI-DI
10885380066009 FDA UDI
FDA Product Code
MUI FDA UDI
GMDN Term
Topical coupling gel, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1570 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Topical coupling gel, sterile

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

Similar devices

Also classified as Topical coupling gel, sterile.

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 903a5ef3-3627-46ca-a26d-a86f28ad36e0 35 fields · synced Jun 8, 2026