FDA UDI
In Commercial Distribution
🇺🇸 United States
SilDerm Scar Spray
DI: 15060295490001
·
Model: 10ml
·
SKINGEN UK LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SilDerm Scar Spray
- Primary DI
- 15060295490001
- Version / Model
- 10ml
- Catalog Number
- SDSCRS10
- Company Name
- SKINGEN UK LTD
- Labeler DUNS
- 216970711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-31
- Public Version
- 2
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- 93a8a5e8-8103-42d4-8492-b4df15857c97
Device Description
Silicone Scar Spray in bottles made of zylinderfl.30, glasklar PETG, 5g, M300 smooth white Spray head. Label material white PP with UV gloss varnish.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | General, Plastic Surgery | 878.4025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44898 | Scar-management dressing, reusable | A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25060295490008 | GS1 | Inner | 12 | In Commercial Distribution | |
| Primary | 15060295490001 | GS1 | ||||
| Package | 35060295490005 | GS1 | Shipper | 12 | In Commercial Distribution |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Flammable