9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm…
9-0 Suture USP / Thread Specifications: Polypropylene, Blue Monofilament, 12 inch (30 cm) / Needle Specifications: ST-000-6, Spatula Tip, straight (0 degrees), length 16 mm, wire 0.15 mm AND Needle Specifications: ST-160-6, Spatula Tip, ½ circle (160 degrees), length 6.2 mm, wire 0.15 mm / # of needles: Double arm
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
Record
Regulatory record for Sutralene | Listed by | Visionary Medical Supplies, Inc., United States |
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K070243 |
| Record published | 2016-06-14 |
| Record revised | 2023-06-02 (version 6) |
Specifications
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, manufacturing date |
| Packaging | Carton of 12, pouch |
| Sizes | Angle 0 to 160 °; length 6.2 to 16 mm; outer diameter 0.15 to 0.38 mm; length 5 to 70 cm |
| UDI direct marking | Exempt |
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.
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.