FDA UDI
In Commercial Distribution
🇺🇸 United States
TM "Rehabilitimed" RP-6P M Comfort
DI: 04823097720066
·
Model: RP-6P M Comfort
·
REABILITIMED TOV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TM "Rehabilitimed" RP-6P M Comfort
- Primary DI
- 04823097720066
- Version / Model
- RP-6P M Comfort
- Catalog Number
- RP-6P M Comfort
- Company Name
- REABILITIMED TOV
- Labeler DUNS
- 364875768
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-04
- Public Version
- 1
- Public Version Date
- 2025-05-12
- Public Version Status
- New
- Public Device Record Key
- a11e5983-baee-4b71-8ff3-6fd53027745a
Device Description
It is a beige hand wrap. Made of durable material with a high cotton content and equipped with an adjustable strap for the neck and upper arm. The height and tightness of the fit to the body is adjusted by means of textile fastener strips on the product straps. Additionally equipped with a belt around the waist for more precise fixation and prevention of hand abduction.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IOY | Support, Arm | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41053 | Elbow orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance designed to encompass the elbow joint to support, align, prevent, or correct deformities/injuries or to improve function of the elbow. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04823097720066 | GS1 |
Customer Contacts
- Phone
- 835 5030395
- [email protected]
- Phone
- +380965139983
- [email protected]
- Phone
- +380937042825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Forearm length from elbow to middle of palm (cm): 33-36 |