Surgimesh®xb
A non woven, non knitted layer reinforcement material made from polypropylene and a silicone layer
1manufacturer
16catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Aspide Medical, United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Record published | 2015-10-23 |
| Record revised | 2025-08-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature; Special storage condition: Keep away from sunlight; Special storage condition: Keep dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TINTRAE1522 | Tonneau 22x15x10cm | In distribution |
| TINTRAR1015 | 10x15cm | In distribution |
| TINTRAS | 14x15cm | In distribution |
| TINTRAR2030 | 20x30cm | In distribution |
| TINTRAOK1522 | Skirted Oval 15x22cm | In distribution |
| TINTRAE3030 | Tonneau 30x30x20cm | In distribution |
| TINTRAO2636 | Ovale 26x36cm | In distribution |
| TINTRAE2226 | Tonneau 26x22x14.6cm | In distribution |
| TINTRACK7 | Skirted Round ø7cm | In distribution |
| TINTRAC15 | Rond ø15cm | In distribution |
| TINTRAXM | 10x15cm | In distribution |
| TINTRAR1415 | 14x15cm | In distribution |
| TINTRAM | Tonneau 22x15x10cm | In distribution |
| TINTRAC12 | Rond ø12.5cm | In distribution |
| TINTRAOK1015 | Skirted Oval 10x15cm | In distribution |
| TINTRAC10 | Rond ø10cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| Parietex | Sofradim Production | 82 |
| DynaMesh | FEG Textiltechnik Forschungs- und Entwicklungsges. mbH | 45 |
| Symbotex | Sofradim Production | 35 |
| Silicone Sheeting Reinforced | Bentec Medical OpCo, LLC. | 33 |
| Parietene | Sofradim Production | 32 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 31 |
| Prolite | Atrium Medical Corporation | 31 |
| Gore Seamguard Bioabsorbable Staple Line Reinforce | W. L. Gore & Associates, Inc. | 30 |
| Surgimesh®wn | Aspide Medical | 28 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120025 | 2012-06-26 |
| K092233 | 2010-06-25 |
| K072974 | 2008-08-18 |
| K061445 | 2007-02-01 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990028 | 2003-12-04 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.