Identity
- Trade Name
- Sound Ergonomics FDA UDI
- Generic Name
- Limb/torso/head restraint, reusable FDA UDI
- Device Name
- Sound Ergonomics Positioning Aids - Arm 1.5in x 16in x 1in 1 per Each FDA UDI
- Model / Reference
- 24117 FDA UDI
- Description
- Sound Ergonomics Positioning Aids - Arm 1.5in x 16in x 1in 1 per Each FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00618125164653 FDA UDI
- FDA Product Code
- KXJ FDA UDI
- GMDN Term
- Limb/torso/head restraint, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Sound Ergonomics by Tidi Products, Llc — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tidi Products, Llc
Sources (1)
- FDA UDI e9c07db3-54b2-4eb1-9da1-d9a70f26bacd 34 fields · synced May 31, 2026