Identity
- Trade Name
- Sage FDA UDI
- Generic Name
- Oral care kit, single-use FDA UDI
- Device Name
- Skin Antisepsis and Oral Cleansing FDA UDI
- Model / Reference
- 9001 FDA UDI
- Description
- Skin Antisepsis and Oral Cleansing FDA UDI
Identifiers
- Catalog Number
- 9001 FDA UDI
- Primary DI / UDI-DI
- 00618029830241 FDA UDI
- FDA Product Code
- EFW FDA UDINSB FDA UDIKXF FDA UDIMAC FDA UDI
- GMDN Term
- Oral care kit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6855 FDA UDI880.6025 FDA UDI878.4014 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
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
Category: Basic manual toothbrushOral care kit, single-useOral care swab
Sage by Sage Products Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 c96975c0-48ec-4104-b35f-02001f80ea70 36 fields · synced May 30, 2026