Identity
- Trade Name
- TM "Rehabilitimed" OT-2 Sp Comfort FDA UDI
- Generic Name
- Clavicle orthosis FDA UDI
- Device Name
- It is a graphite-colored shoulder brace. The posture corrector is presented in the form of two shoulder straps made of soft material, which are worn on the shoulder joints in the form of rings and, crossing, are tightened on the back in the form of a fabric figure eight on a round pad located in the interscapular region using a Velcro fastener at the ends of the shoulder straps. FDA UDI
- Model / Reference
- OT-2 Sp Comfort FDA UDI
- Description
- It is a graphite-colored shoulder brace. The posture corrector is presented in the form of two shoulder straps made of soft material, which are worn on the shoulder joints in the form of rings and, crossing, are tightened on the back in the form of a fabric figure eight on a round pad located in the interscapular region using a Velcro fastener at the ends of the shoulder straps. FDA UDI
Identifiers
- Catalog Number
- OT-2 Sp Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097717561 FDA UDI
- FDA Product Code
- IQJ FDA UDI
- GMDN Term
- Clavicle orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3490 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Clavicle orthosis
TM "Rehabilitimed" OT-2 Sp Comfort by Reabilitimed Tov — 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
- Reabilitimed Tov
Sources (1)
- FDA UDI b4a8d5e0-fcfe-411d-8690-aed75d7026b0 36 fields · synced Jun 1, 2026