FDA UDI
In Commercial Distribution
🇺🇸 United States
TM "Rehabilitimed" BR-2 M Comfort
DI: 04823097721667
·
Model: BR-2 M 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" BR-2 M Comfort
- Primary DI
- 04823097721667
- Version / Model
- BR-2 M Comfort
- Catalog Number
- BR-2 M Comfort
- Company Name
- REABILITIMED TOV
- Labeler DUNS
- 364875768
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-19
- Public Version
- 1
- Public Version Date
- 2025-06-27
- Public Version Status
- New
- Public Device Record Key
- 79ecb07d-bd3f-462e-9067-fe752c50de75
Device Description
It is a white chest bandage graphite color. The part of the bandage that fits the back is made of elastic fabric, and the front and side parts are made of a multilayer material (special velour fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth, equipped with 2 plastic stiffening ribs.
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 |
|---|---|---|---|---|
| IPX | Orthosis, Rib Fracture, Soft | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33031 | Lumbar spine orthosis | A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04823097721667 | 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 | Thorax circumference (cm): 90-103 | ||
| Device Size Text, specify | Thorax circumference (inch): 35-40,5 |