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McKesson

FDA UDI

Class I (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Non-woven gauze pad FDA UDI
Device Name
Sterile fluff Gauze sponges FDA UDI
Model / Reference
16-42626 FDA UDI
Description
Sterile fluff Gauze sponges FDA UDI

Identifiers

Primary DI / UDI-DI
10612479118895 FDA UDI
FDA Product Code
NAB FDA UDI
GMDN Term
Non-woven gauze pad FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4014 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

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Non-woven gauze pad

McKesson by Mckesson Medical-Surgical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-woven gauze pad.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI ce25d842-a214-4b1f-8be9-2b4a305573be 33 fields · synced Jun 8, 2026