Identity
- Trade Name
- Gurunanda Ultimate Oral Care Combo FDA UDI
- Generic Name
- Oral lavage system FDA UDI
- Device Name
- Portable Water Flosser & Electric Toothbrush Kit with Charging Stand, Power Adapter & Replaceable Brush Heads FDA UDI
- Model / Reference
- H100/H6PLUS FDA UDI
- Description
- Portable Water Flosser & Electric Toothbrush Kit with Charging Stand, Power Adapter & Replaceable Brush Heads FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810051084313 FDA UDI
- FDA Product Code
- EFS FDA UDIJEQ FDA UDI
- GMDN Term
- Oral lavage system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6510 FDA UDI872.6865 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic electric toothbrushOral lavage system
Gurunanda Ultimate Oral Care Combo by Gurunanda 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
- Gurunanda Llc
Sources (1)
- FDA UDI 42e407e8-9267-4ba9-a080-2da4e5c93440 33 fields · synced Jun 1, 2026