Technical Products
silicone sheet radiopaque reinforced
1manufacturer
143catalogue numbers in this listing
1510(k) clearance
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 | Technical Products, Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K971472 |
| Record published | 2016-09-15 |
| Record revised | 2024-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 500-1S23 | .005″x2″x3″ | In distribution |
| 501-3S68 | .020″x6″x8″ Reinforced | In distribution |
| 400-60 6×8 | .060″x6″x8″ | In distribution |
| 501-1S46 | .015″x4″x6″ Reinforced | In distribution |
| 500-6 12×12 | .030″x12″x12″ | In distribution |
| 501-1 4×4 | .015″x4″x4″ | In distribution |
| 501-3S26 | .020″x2″x6″ Reinforced | In distribution |
| 403-30 12×12 | .030″x 12″ x 12″ | In distribution |
| 501-2 12×12 | .010″x12″x12″ | In distribution |
| 500-6 4×8 | .030″x4″x8″ | In distribution |
| 400-15 4×8 | .015″x4″x8″ | In distribution |
| 501-3 6×8 | .020″x6″x8″ | In distribution |
| 502-3 4×8 | .080″x4″x8″ | In distribution |
| 500-5 4×4 | .020″x4″x4″ | In distribution |
| 500-1 4×8 | .005″x4″x8″ | In distribution |
| 500-5S23 | .020″x2″x3″ | In distribution |
| 403-15 12×12 | .015″x 12″ x 12″ | In distribution |
| 403-40 6×8 | .040″x6″x8″ | In distribution |
| 502-2 6×8 | .060″x6″x8″ | In distribution |
| 501-1S68 | .015″x6″x8″ Reinforced | In distribution |
| 501-1 12×12 | .015″x12″x12″ | In distribution |
| 501-7 12×12 | .040″x12″x12″ | In distribution |
| 400-20 4×8 | .020″x4″x8″ | In distribution |
| 501-2 4×8 | .010″x4″x8″ | In distribution |
| 500-3S23 | .010″x2″x3″ | In distribution |
| 501-3S23 | .020″x2″x3″ Reinforced | In distribution |
| 501-1S1212 | .015″x12″x12″ Reinforced | In distribution |
| 501-5S23 | .030″x2″x3″ Reinforced | In distribution |
| 500-4 4×4 | .015″x4″x4″ | In distribution |
| 400-30 4×8 | .030″x4″x8″ | In distribution |
| 501-7 4×8 | .040″x4″x8″ | In distribution |
| 403-20 12×12 | .020″ x 12″ x 12″ | In distribution |
| 500-9 12×12 | .060″x12″x12″ | In distribution |
| 501-1 4×8 | .015″x4″x8″ | In distribution |
| 400-20 12×12 | .020″ x 12″ x 12″ | In distribution |
| 400-60 12×12 | .060″x 12″ x 12″ | In distribution |
| 500-7 6×8 | .040″x6″x8″ | In distribution |
| 500-4 6×8 | .015″x6″x8″ | In distribution |
| 403-15 6×8 | .015″x6″x8″ | In distribution |
| 501-9 4×8 | .060″x4″x8″ | In distribution |
| 400-15 6×8 | .015″x6″x8″ | In distribution |
| 501-2S1418 | .010″x14″x18″ Reinforced | In distribution |
| 500-1 12×12 | .005″x12″x12″ | In distribution |
| 500-5 12×12 | .020″x12″x12″ | In distribution |
| 501-3S1212 | .020″x12″x12″ Reinforced | In distribution |
| 501-5S1115 | .030″x11″x15″ Reinforced | In distribution |
| 502-3S48 | .080″x4″x8″ | In distribution |
| 501-3 4×8 | .020″x4″x8″ | In distribution |
| 500-9 4×4 | .060″x4″x4″ | In distribution |
| 403-60 4×8 | .060″x4″x8″ | In distribution |
| 500-2 4×8 | .002″x4″x8″ | In distribution |
| 500-7S48 | .040″x4″x8″ | In distribution |
| 500-6S48 | .030″x4″x8″ | In distribution |
| 400-40 6×8 | .040″x6″x8″ | In distribution |
| 501-2S68 | .010″x6″x8″ Reinforced | In distribution |
| 500-5S68 | .020″x6″x8″ | In distribution |
| 500-2 6×8 | .002″x6″x8″ | In distribution |
| 500-7S68 | .040″x6″x8″ | In distribution |
| 403-15 4×4 | .015″x4″x4″ | In distribution |
| 500-3 4×4 | .010″x4″x4″ | In distribution |
| 500-6 4×4 | .030″x4″x4″ | In distribution |
| 400-30 6×8 | .030″x6″x8″ | In distribution |
| 400-40 12×12 | .040″x 12″ x 12″ | In distribution |
| 501-1S23 | .015″x2″x3″ Reinforced | In distribution |
| 500-7S23 | .040″x2″x3″ | In distribution |
| 403-20 4×8 | .020″x4″x8″ | In distribution |
| 501-7S46 | .040″x4″x6″ Reinforced | In distribution |
| 500-7 4×8 | .040″x4″x8″ | In distribution |
| 403-20 4×4 | .020″x4″x4″ | In distribution |
| 500-4 4×8 | .015″x4″x8″ | In distribution |
| 500-7 4×4 | .040″x4″x4″ | In distribution |
| 501-7 6×8 | .040″x6″x8″ | In distribution |
| 400-60 4×8 | .060″x4″x8″ | In distribution |
| 502-1 4×8 | .040″x4″x8″ | In distribution |
| 501-5 4×8 | .030″x4″x8″ | In distribution |
| 501-0S23 | .007″x2″x3″ Reinforced | In distribution |
| 500-3 4×8 | .010″x4″x8″ | In distribution |
| 500-3S48 | .010″x4″x8″ | In distribution |
| 501-5 6×8 | .030″x6″x8″ | In distribution |
| 400-30 4×4 | .030″x4″x4″ | In distribution |
| 500-9S68 | .060″x6″x8″ | In distribution |
| 502-1 4×4 | .040″x4″x4″ | In distribution |
| 502-2 12×12 | .060″x12″x 12″ | In distribution |
| 403-40 12×12 | .040″x 12″ x 12″ | In distribution |
| 501-1 6×8 | .015″x6″x8″ | In distribution |
| 500-9 6×8 | .060″x6″x8″ | In distribution |
| 502-1 12×12 | .040″x 12″x 12″ | In distribution |
| 400-20 6×8 | .020″x6″x8″ | In distribution |
| 500-1 6×8 | .005″x6″x8″ | In distribution |
| 403-30 6×8 | .030″x6″x8″ | In distribution |
| 501-3 12×12 | .020″x12″x12″ | In distribution |
| 500-3S68 | .010″x6″x8″ | In distribution |
| 501-0 12×12 | .007″x12″x12″ | In distribution |
| 500-3 12×12 | .010″x12″x12″ | In distribution |
| 400-60 4×4 | .060″x4″x4″ | In distribution |
| 403-40 4×4 | .040″x4″x4″ | In distribution |
| 400-15 12×12 | .015″x 12″ x 12″ | In distribution |
| 403-20 6×8 | .020″x6″x8″ | In distribution |
| 501-2 6×8 | .010″x6″x8″ | In distribution |
| 502-2 4×4 | .060″x4″x4″ | In distribution |
| 501-2 4×4 | .010″x4″x4″ | In distribution |
| 501-9 4×4 | .060″x4″x4″ | In distribution |
| 500-6 6×8 | .030″x6″x8″ | In distribution |
| 500-5 4×8 | .020″x4″x8″ | In distribution |
| 500-4 12×12 | .015″x12″x12″ | In distribution |
| 501-3S612 | .020″x6″x12″ Reinforced | In distribution |
| 502-3 12×12 | .080″x12″x12″ | In distribution |
| 403-30 4×8 | .030″x4″x8″ | In distribution |
| 403-30 4×4 | .030″x4″x4″ | In distribution |
| 501-5 12×12 | .030″x12″x12″ | In distribution |
| 403-60 4×4 | .060″x4″x4″ | In distribution |
| 500-1 4×4 | .005″x4″x4″ | In distribution |
| 500-3 6×8 | .010″x6″x8″ | In distribution |
| 501-9 6×8 | .060″x6″x8″ | In distribution |
| 403-60 12×12 | .060″x 12″ x 12″ | In distribution |
| 501-3 4×4 | .020″x4″x4″ | In distribution |
| 501-7S1212 | .040″x12″x12″ Reinforced | In distribution |
| 400-40 4×8 | .040″x4″x8″ | In distribution |
| 500-2 12×12 | .002″x12″x12″ | In distribution |
| 501-7S23 | .040″x2″x3″ Reinforced | In distribution |
| 500-9 4×8 | .060″x4″x8″ | In distribution |
| 500-1S68 | .005″x6″x8″ | In distribution |
| 502-1 6×8 | .040″x 6″x 8″ | In distribution |
| 500-2 4×4 | .002″x4″x4″ | In distribution |
| 400-20 4×4 | .020″x4″x4″ | In distribution |
| 501-9 12×12 | .060″x12″x12″ | In distribution |
| 400-15 4×4 | .015″x4″x4″ | In distribution |
| 500-5S48 | .020″x4″x8″ | In distribution |
| 501-5S68 | .030″x6″x8″ Reinforced | In distribution |
| 501-0S68 | .007″x6″x8″ Reinforced | In distribution |
| 502-2 4×8 | .060″x4″x8″ | In distribution |
| 502-3 4×4 | .080″x4″x4″ | In distribution |
| 403-15 4×8 | .015″x4″x8″ | In distribution |
| 400-40 4×4 | .040″x4″x4″ | In distribution |
| 500-5 6×8 | .020″x6″x8″ | In distribution |
| 501-5 4×4 | .030″x4″x4″ | In distribution |
| 501-7S68 | .040″x6″x8″ Reinforced | In distribution |
| 403-40 4×8 | .040″x4″x8″ | In distribution |
| 502-3 6×8 | .080″x6″x8″ | In distribution |
| 403-60 6×8 | .060″x6″x8″ | In distribution |
| 500-7 12×12 | .040″x12″x12″ | In distribution |
| 501-7 4×4 | .040″x4″x4″ | In distribution |
| 400-30 12×12 | .030″x 12″ x 12″ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Bard | Davol Inc. | 27 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971472 | 1997-07-01 |
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.