Identity
- Trade Name
- Duatene FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
- Device Name
- Bilayer Mesh Monofilament Polypropylene FDA UDI
- Model / Reference
- DTN07R FDA UDI
- Description
- Bilayer Mesh Monofilament Polypropylene FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521726567 FDA UDI
- 510(k) Number
- K172395 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Height — 4.5 Centimeter FDA UDIWidth — 10 Centimeter FDA UDIOuter Diameter — 7 Centimeter FDA UDI
Duatene by Sofradim Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172395 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sofradim Production
Sources (1)
- FDA UDI bf4db014-9ce7-45d3-90d6-7ae2a34b4462 37 fields · synced May 30, 2026