FDA UDI
In Commercial Distribution
🇺🇸 United States
TM "Rehabilitimed" TUTOR-7K UNI Right Comfort
DI: 04823097722800
·
Model: TUTOR-7K UNI Right 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" TUTOR-7K UNI Right Comfort
- Primary DI
- 04823097722800
- Version / Model
- TUTOR-7K UNI Right Comfort
- Catalog Number
- TUTOR-7K UNI Right Comfort
- Company Name
- REABILITIMED TOV
- Labeler DUNS
- 364875768
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-17
- Public Version
- 1
- Public Version Date
- 2025-05-26
- Public Version Status
- New
- Public Device Record Key
- 669b83d9-7c8b-4826-b9d3-ce5e17d7bfaf
Device Description
The graphite-colored wrist-hand orthosis provides external semi-rigid dosed fixation of the carpal joint to the lower third of the forearm. Reinforced with a rigid wide profiled splint with an angle of 60 degrees to the hand relative to the forearm, located along the palm. Made of multilayer material with a cotton layer to the body and polyamide on the outside.
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 |
|---|---|---|---|---|
| ITM | Cage, Knee | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04823097722800 | 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 | Wrist circumference (inch): 6-10 |