FDA UDI
In Commercial Distribution
🇺🇸 United States
Mepitel® Film
DI: 00050428594353
·
Model: 296288
·
Mölnlycke Health Care AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Mepitel® Film
- Primary DI
- 00050428594353
- Version / Model
- 296288
- Company Name
- Mölnlycke Health Care AB
- Labeler DUNS
- 631770658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-18
- Public Version
- 1
- Public Version Date
- 2020-09-28
- Public Version Status
- New
- Public Device Record Key
- 225f5401-0fd3-4575-8bf3-b1dc1f5543a2
Device Description
Mepitel Film 4x4,8in/10x12cm, 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 |
|---|---|---|---|---|
| NAD | Dressing, wound, occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58316 | Synthetic polymer semi-permeable film dressing, wound-nonadherent | A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed. It may be applied directly to tissue or used in combination with other dressings (e.g., gels) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, shallow ulcers). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07323190208678 | GS1 | 7 | Not in Commercial Distribution | 1995-12-31 | |
| Primary | 00050428594353 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 25.0 | Millimeter | |
| Length | 212.0 | Millimeter | |
| Height | 155.0 | Millimeter |