Identity
- Trade Name
- TM "Rehabilitimed" RP-6P S Comfort FDA UDI
- Generic Name
- Elbow orthosis FDA UDI
- Device Name
- The arm support scarf provides a medium degree of fixation of the elbow joint and shoulder girdle in turquoise blue. Equipped with a belt around the waist for more precise fixation and prevention of arm abduction. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm. FDA UDI
- Model / Reference
- RP-6P S Comfort FDA UDI
- Description
- The arm support scarf provides a medium degree of fixation of the elbow joint and shoulder girdle in turquoise blue. Equipped with a belt around the waist for more precise fixation and prevention of arm abduction. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm. FDA UDI
Identifiers
- Catalog Number
- RP-6P S Comfort FDA UDI
- Primary DI / UDI-DI
- 04823097723500 FDA UDI
- FDA Product Code
- IOY FDA UDI
- GMDN Term
- Elbow orthosis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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: Elbow orthosis
TM "Rehabilitimed" RP-6P S 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 2b583c3e-8641-4378-a0b4-161b0e2fcb7c 36 fields · synced Jun 6, 2026