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Gum

FDA UDI

Class I (US FDA UDI)

by Sunstar Americas, Inc.

Identity

Trade Name
GUM FDA UDI
Generic Name
Dental floss FDA UDI
Device Name
Mixed Flosser Wing FDA UDI
Model / Reference
9935 FDA UDI
Description
Mixed Flosser Wing FDA UDI

Identifiers

Catalog Number
RA FDA UDI
Primary DI / UDI-DI
00070942007276 FDA UDI
FDA Product Code
JES FDA UDI
GMDN Term
Dental floss FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6390 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental floss

Gum by Sunstar Americas, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental floss.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 802afca4-f66f-4a3f-99a1-6c90b99cc3bc 34 fields · synced May 30, 2026