Identity
- Trade Name
- SmartByte Device FDA UDI
- Generic Name
- Oral intake restriction kit FDA UDI
- Device Name
- Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake. FDA UDI
- Model / Reference
- SI-001.01 FDA UDI
- Description
- Custom made oral device used during meals to reduce the capacity of the oral cavity and slow/reduce food intake. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860001615326 FDA UDI
- 510(k) Number
- K171165 FDA UDI
- FDA Product Code
- ONY FDA UDI
- GMDN Term
- Oral intake restriction kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5981 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral intake restriction kit
SmartByte Device by Scientific Intake — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Scientific Intake
Sources (1)
- FDA UDI 6e6e6e2a-9b31-40be-840f-a9e0a9f6273d 34 fields · synced May 30, 2026