Identity
- Trade Name
- GUM® FDA UDI
- Generic Name
- Basic manual toothbrush FDA UDI
- Device Name
- 12 TRAVEL TOOTHBRUSHES FDA UDI
- Model / Reference
- 153 FDA UDI
- Description
- 12 TRAVEL TOOTHBRUSHES FDA UDI
Identifiers
- Catalog Number
- PQA FDA UDI
- Primary DI / UDI-DI
- 00070942751605 FDA UDI
- FDA Product Code
- EFW FDA UDI
- GMDN Term
- Basic manual toothbrush FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Height — 186 Millimeter FDA UDIWidth — 20.6 Millimeter FDA UDIDepth — 33 Millimeter FDA UDI
Category: Basic manual toothbrush
Gum® by Sunstar Americas, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic manual toothbrush.
- QUALA — NATIONAL DISTRIBUTION & CONTRACTING, INC. · Class I
- Euro Tech Toothbrush — Safco Dental Supply · Class I
- FOSHAN DRAGON — Foshan Dragon Technology Co., Ltd. · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- VIACOM INTERNATIONAL INC. — Powerlink Creations (Zhongshan) Corporation · Class I
- Tooth Keri 4 Songs Kids Toothbrush — Supermouth LLC · Class I
- PRO-SYS — BENCO DENTAL SUPPLY CO. · Class I
- e-sarang — B&B Company Co., Ltd. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunstar Americas, Inc.
Sources (1)
- FDA UDI e1c346b7-336f-4275-a719-e579c214212d 36 fields · synced May 30, 2026