FDA UDI
In Commercial Distribution
🇺🇸 United States
Mepiform®
DI: 07323190127108
·
Model: 293288
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Mepiform®
- Primary DI
- 07323190127108
- Version / Model
- 293288
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-28
- Public Version
- 1
- Public Version Date
- 2020-08-05
- Public Version Status
- New
- Public Device Record Key
- 2f96a568-e766-4459-9516-b9661a8040fa
Device Description
Mepiform 2x3in/5x7,5cm, CVS
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
- 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 |
|---|---|---|---|---|
| 47772 | Scar management dressing, single-use, sterile | A sterile covering made of, or coated with, a silicone-based substance (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 a flexible or 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. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07323190105229 | GS1 | 5 | Not in Commercial Distribution | 1995-12-31 | |
| Package | 00050428305072 | GS1 | 3 | Not in Commercial Distribution | 1995-12-31 | |
| Primary | 07323190127108 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.0 | Millimeter | |
| Width | 0.0 | Millimeter | |
| Height | 0.0 | Millimeter |