FDA UDI
In Commercial Distribution
🇺🇸 United States
TM "Rehabilitimed" RP-6U-10 XL Comfort
DI: 04823097720110
·
Model: RP-6U-10 XL Comfort
·
REABILITIMED TOV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- TM "Rehabilitimed" RP-6U-10 XL Comfort
- Primary DI
- 04823097720110
- Version / Model
- RP-6U-10 XL Comfort
- Catalog Number
- RP-6U-10 XL 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
- 11132c4c-f3f0-468f-951c-6f92eb1fc1fd
Device Description
It is an Orthosis for the shoulder joint with an abduction pad, graphite color. Equipped with an adjustable strap for the neck and upper arm, equipped with a pad for abduction installation at an angle of 10 degrees, and equipped with a belt around the waist for more precise fixation and providing an abduction position in the postoperative period.
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 | 04823097720110 | 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 (cm): >40 |