FDA UDI
In Commercial Distribution
🇺🇸 United States
TM "Rehabilitimed" S-3 S Comfort
DI: 04823097716861
·
Model: S-3 S Comfort
·
REABILITIMED TOV
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TM "Rehabilitimed" S-3 S Comfort
- Primary DI
- 04823097716861
- Version / Model
- S-3 S Comfort
- Catalog Number
- S-3 S 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
- ae65019a-b72d-4e8a-b451-0de673f8738c
Device Description
It is a surgical bandage for the abdominal wall, beige in color. The part of the bandage adjacent to the back and the right front-side parts that perform fixation are made of elastic bandage fabric, and the left front-side part located on the abdomen is made of multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), with 2 plastic stiffening ribs. The height of the corset is 24 cm.
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 |
|---|---|---|---|---|
| KTD | Orthosis, Abdominal | Physical Medicine | 890.3490 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47217 | Abdominal binder, reusable | A strip, roll or tube of fabric or polymer material intended to be applied to the abdomen to support relaxed abdominal walls (e.g., after surgery, during pregnancy) or to provide support for another device (e.g., dressing, ultrasound transducer, percutaneous lead). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04823097716861 | 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 | Hips 10 cm below the waistline (cm): 77-87 | ||
| Device Size Text, specify | Bandage length (cm): 93-97 |