FDA UDI
In Commercial Distribution
🇺🇸 United States
Sion Biotext Medical Ltd.
DI: 37290101427811
·
Model: 1
·
SION BIOTEXT MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Sion Biotext Medical Ltd.
- Primary DI
- 37290101427811
- Version / Model
- 1
- Catalog Number
- 54W209-1206-912
- Company Name
- SION BIOTEXT MEDICAL LTD
- Labeler DUNS
- 532775194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-09-19
- Public Version
- 1
- Public Version Date
- 2023-09-27
- Public Version Status
- New
- Public Device Record Key
- 035c2fa9-8c1e-4366-add2-9871d5e7f661
Device Description
Adhesive Remover is a uniquely formulated solution which ensures pain free removal of medical adhesive products.
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
- Yes
- 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 |
|---|---|---|---|---|
| KOY | Degreaser, Skin, Surgical | General, Plastic Surgery | 878.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60494 | Patient medical adhesive remover | A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 37290101427811 | GS1 | ||||
| Unit of Use | 07290101427810 | GS1 |