3 catalogue numbers from 8682P-IMC, listed by C P Medical Inc., 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 Polypropylene | Listed by | C P Medical Inc. |
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Premarket notification | Exempt |
| Record published | 2017-08-03 |
| Record revised | 2023-06-02 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 12 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
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.