FDA UDI
In Commercial Distribution
🇺🇸 United States
TM "Rehabilitimed" OT-1D-4 L Comfort
DI: 04823097722596
·
Model: OT-1D-4 L Comfort
·
REABILITIMED TOV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TM "Rehabilitimed" OT-1D-4 L Comfort
- Primary DI
- 04823097722596
- Version / Model
- OT-1D-4 L Comfort
- Catalog Number
- OT-1D-4 L 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
- 52332094-38e0-4737-ba15-ab97bdd75df2
Device Description
The beige posture corrector provides a medium degree of fixation due to 4 modeled metal stiffeners. The orthosis helps to straighten the spine and ensure its proper position. Made of durable elastic bandage fabric made of polyamide and elastane.
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 |
|---|---|---|---|---|
| IPT | Orthosis, Thoracic | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41042 | Thoracic spine orthosis | A prefabricated (non-customized) orthopaedic corset designed to encompasses the thoracic spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine through compression of the abdomen. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04823097722596 | GS1 |
Customer Contacts
- Phone
- 835 5030395
- [email protected]
- Phone
- +380965139983
- [email protected]
- Phone
- +380937042825
- [email protected]