Identity
- Trade Name
- Symbotex FDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
- Device Name
- Composite Mesh Monofilament Polyester with Absorbable Collagen Film and Marking FDA UDI
- Model / Reference
- SYM20 FDA UDI
- Description
- Composite Mesh Monofilament Polyester with Absorbable Collagen Film and Marking FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521593435 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Extra-gynaecological surgical mesh, composite-polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Commercial Distribution
- 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
- Outer Diameter — 20 Centimeter FDA UDI
Category: Extra-gynaecological surgical mesh, composite-polymer
Symbotex by Sofradim Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, composite-polymer.
- ULTRAPRO — Johnson & Johnson International Inc. · Class II
- VENTRALIGHT — Davol Inc. · Class II
- VENTRALIGHT — Davol Inc. · Class II
- Ti-MESH — pfm medical titanium gmbh · Class II
- Surgipro — Covidien LP · Class II
- Surgipro — Covidien LP · Class II
- Surgipro — Covidien LP · Class II
- GORE SYNECOR Biomaterial — W. L. GORE & ASSOCIATES, INC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sofradim Production
Sources (1)
- FDA UDI 5a4c2dce-9689-4b6b-8683-54a26d122254 35 fields · synced May 30, 2026