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McKesson

FDA UDI

Class II (US FDA UDI)

by Mckesson Medical-Surgical Inc.

Identity

Trade Name
McKesson FDA UDI
Generic Name
Fluoride gel FDA UDI
Device Name
5% Sodium Fluoride Varnish BUBBLEGUM WITH XYLITOL 0.4 mL FDA UDI
Model / Reference
184-FV35 FDA UDI
Description
5% Sodium Fluoride Varnish BUBBLEGUM WITH XYLITOL 0.4 mL FDA UDI

Identifiers

Primary DI / UDI-DI
20612479229314 FDA UDI
FDA Product Code
LBH FDA UDI
GMDN Term
Fluoride gel FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3260 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Fluoride gel

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

Similar devices

Also classified as Fluoride gel.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mckesson Medical-Surgical Inc.

Sources (1)

  • FDA UDI 4b1230a1-531e-44c6-8671-83fde6971805 33 fields · synced Jun 8, 2026