Identity
- Trade Name
- Toothette Oral Care FDA UDI
- Generic Name
- Oral care kit, single-use FDA UDI
- Device Name
- Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse FDA UDI
- Model / Reference
- 6592 FDA UDI
- Description
- Q2 Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse FDA UDI
Identifiers
- Catalog Number
- 6592 FDA UDI
- Primary DI / UDI-DI
- 00618029821331 FDA UDI
- FDA Product Code
- KXF FDA UDIJOL FDA UDINSB FDA UDI
- GMDN Term
- Oral care kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI880.6740 FDA UDI872.6855 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Combination Product
Yes
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
Toothette Oral Care by Sage Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Sage Products Llc
Sources (1)
- FDA UDI 2ef7c90f-4253-440c-86ef-f58ed6030145 37 fields · synced May 30, 2026