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
- SYM12 FDA UDI
- Description
- Composite Mesh,Monofilament Polyester with Absorbable Collagen Film and Marking FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521190344 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 — 12 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
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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 b5bc7b26-6eef-42a6-8ef6-429d64077e74 35 fields · synced Jun 6, 2026