2 catalogue numbers from J8683N, listed by Surgical Specialties México, S. de R.L. de C.V., under Suture, Nonabsorbable, Synthetic, Polypropylene. 3 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
Record
Regulatory record for Ds18 4-0 Bl Ppn 18″/45cm | Listed by | Surgical Specialties México, S. de R.L. de C.V. |
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Record published | 2015-10-21 |
| Record revised | 2024-11-11 (version 9) |
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 |
| Packaging | Box of 12, box of 36 |
| 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.