Silicone Sheeting Reinforced
33 catalogue numbers from PR72034-08R, listed by Bentec Medical OpCo, LLC., United States, under Mesh, Surgical, Polymeric. 1 manufacturer in China is registered for this product code.
1manufacturer
33catalogue numbers in this listing
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 | Bentec Medical OpCo, LLC., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| 510(k) | K840172 |
| Record published | 2017-01-11 |
| Record revised | 2024-02-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PR72034-08R | In distribution | ||
| PR72034-06R | In distribution | ||
| PR72034-407R | In distribution | ||
| PR72034-55R | 2 | In distribution | |
| PR72034-03SPR | In distribution | ||
| PR72034-10R | In distribution | ||
| PR72034-05R | In distribution | ||
| PR72034-02R | In distribution | ||
| PR72034-63R | 2 | In distribution | |
| PR72034-07SPR | 2 | In distribution | |
| PR72034-010SPR | In distribution | ||
| PR72034-60R | 2 | In distribution | |
| PR72034-62R | 2 | In distribution | |
| PR72034-04SPR | In distribution | ||
| PR72034-54R | 2 | In distribution | |
| PR72034-007R | In distribution | ||
| PR72034-15SPR | In distribution | ||
| PR72034-07R | In distribution | ||
| PR72034-12R | In distribution | ||
| PR72034-41R | In distribution | ||
| PR72034-52R | 2 | In distribution | |
| PR72034-03R | In distribution | ||
| PR72034-64R | 2 | In distribution | |
| PR72034-01SPR | In distribution | ||
| PR72034-44R | In distribution | ||
| PR72034-04R | In distribution | ||
| PR72034-53R | 2 | In distribution | |
| PR72034-42R | In distribution | ||
| PR72034-43R | In distribution | ||
| PR72034-01R | In distribution | ||
| PR72034-51R | 2 | In distribution | |
| PR72034-14R | In distribution | ||
| PR72034-02SPR | 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 |
| 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 |
| Bard | Davol Inc. | 27 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
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.