FDA UDI
In Commercial Distribution
🇺🇸 United States
Meshgraft skin expansion system
DI: ENOU1986NOU0
·
Model: 1986NOU
·
Nouvag AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Meshgraft skin expansion system
- Primary DI
- ENOU1986NOU0
- Version / Model
- 1986NOU
- Company Name
- Nouvag AG
- Labeler DUNS
- 480610476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-21
- Public Version
- 1
- Public Version Date
- 2018-09-21
- Public Version Status
- New
- Public Device Record Key
- e2f7e5aa-9bcd-475a-99d7-1f2631d1d927
Device Description
Meshgraft skin expansion system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FZW | Expander, Surgical, Skin Graft | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13614 | Skin graft mesher | A manual surgical device used to perforate a skin graft (a section of donor skin from another part of the patient's body) with a pattern of lacerations (cuts) before the skin is grafted to the area being treated on the patient. The skin may be placed on a skin graft carrier to better support it and will typically be run through an instrument with a row of cutting wheels, or be subjected to a rolling drum with a handle and cutting blades, to improve graft stretch and permeability and facilitate graft conformity and healing. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENOU1986NOU0 | HIBCC |
Customer Contacts
- Phone
- +41718466600
- [email protected]