FDA UDI
In Commercial Distribution
🇺🇸 United States
Sion Biotext Medical Ltd.
DI: 17290101427800
·
Model: 1
·
SION BIOTEXT MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Sion Biotext Medical Ltd.
- Primary DI
- 17290101427800
- Version / Model
- 1
- Catalog Number
- 54W211-1205-912
- Company Name
- SION BIOTEXT MEDICAL LTD
- Labeler DUNS
- 532775194
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- 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
- 9abf5f69-1b1c-4277-9e39-645ed85fd000
Device Description
Protective Barrier is a liquid film-forming dressing that, upon application to intact skin, forms a protective film to help reduce friction during removal of tapes and films. It leaves a thin breathable film on the skin, which protects it against potential damage. It dries within seconds and does not build up residue on the skin, leaving you ready to apply a new barrier. The product's discreet packaging makes it practical for traveling or use on-the-go.
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 |
|---|---|---|---|---|
| NEC | Bandage, Liquid, Skin Protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65285 | Skin adhesive protective material | A liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. 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 | 17290101427800 | GS1 | ||||
| Unit of Use | 07290101427803 | GS1 |