Identity
- Trade Name
- SML FDA UDI
- Generic Name
- Tongue-retaining sleep-disordered breathing orthosis FDA UDI
- Device Name
- T.R.D. FDA UDI
- Model / Reference
- 63120S FDA UDI
- Description
- T.R.D. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D85463120S1 FDA UDI
- FDA Product Code
- LRK FDA UDI
- GMDN Term
- Tongue-retaining sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 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
Yes
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tongue-retaining sleep-disordered breathing orthosis
Sml by Selane Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tongue-retaining sleep-disordered breathing orthosis.
- Good Morning Snore Solution — Mpowrx Health and Wellness Products 2012, Inc. · Class II
- SML — Selane Products, Inc. · Class II
- SML — Selane Products, Inc. · Class II
- SML — Selane Products, Inc. · Class II
- SML — Selane Products, Inc. · Class II
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
- Selane Products, Inc.
Sources (1)
- FDA UDI e1f5dac2-7b4d-4dcd-8881-83e2d018fda8 33 fields · synced Jun 1, 2026