Polypro
83 catalogue numbers from 8975P, listed by C P Medical Inc., under Suture, Nonabsorbable, Synthetic, Polypropylene. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
83catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| 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 |
| Record published | 2015-09-24 |
| Record revised | 2023-06-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8975P | In distribution | |
| 8831P | In distribution | |
| 130P | In distribution | |
| 8635P | In distribution | |
| 8686P | In distribution | |
| 8926P | In distribution | |
| 8741P | In distribution | |
| 8629P | In distribution | |
| 8703P | In distribution | |
| 1011P | In distribution | |
| 8976P | In distribution | |
| 8526P | In distribution | |
| 8524P | In distribution | |
| 8727P | In distribution | |
| 8522P | In distribution | |
| 8424P | In distribution | |
| 8557P | In distribution | |
| 8710P | In distribution | |
| 8681P | In distribution | |
| 8881P | In distribution | |
| 1698P | In distribution | |
| 8618P | In distribution | |
| 8690P | In distribution | |
| 8533P | In distribution | |
| 8699P | In distribution | |
| 8721P | In distribution | |
| 8687P | In distribution | |
| 8709P | In distribution | |
| 8661P | In distribution | |
| 8581P | In distribution | |
| 8704P | In distribution | |
| 8974P | In distribution | |
| 8735P | In distribution | |
| 8617P | In distribution | |
| 1013P | In distribution | |
| 8840P | In distribution | |
| 8832P | In distribution | |
| 8935P | In distribution | |
| 1031P | In distribution | |
| 8623P | In distribution | |
| 8683P | In distribution | |
| 8648P | In distribution | |
| 8871P | In distribution | |
| 8665P | In distribution | |
| 8306P | In distribution | |
| 8925P | In distribution | |
| 8695P | In distribution | |
| 1699P | In distribution | |
| 8411P | In distribution | |
| 8977P | In distribution | |
| 8525P | In distribution | |
| 8807P | In distribution | |
| 8434P | In distribution | |
| 8882P | In distribution | |
| 1695P | In distribution | |
| 8843P | In distribution | |
| 8702P | In distribution | |
| 8689P | In distribution | |
| 8697P | In distribution | |
| 9007P | In distribution | |
| 8435P | In distribution | |
| 8706P | In distribution | |
| 8934P | In distribution | |
| 5692P | In distribution | |
| 8634P | In distribution | |
| 8870P | In distribution | |
| 8423P | In distribution | |
| 8422P | In distribution | |
| 8684P | In distribution | |
| 8732P | In distribution | |
| 8842P | In distribution | |
| 8720P | In distribution | |
| 8711P | In distribution | |
| 8833P | In distribution | |
| 8425P | In distribution | |
| 8707P | In distribution | |
| 8523P | In distribution | |
| 8880P | In distribution | |
| 8805P | In distribution | |
| 8685P | In distribution | |
| 8534P | In distribution | |
| 8682P | In distribution | |
| 8558P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| Premilene | B Braun Surgical SA | 1,247 |
| Optilene | B Braun Surgical SA | 1,110 |
| Prolene | Ethicon, Inc. | 765 |
| Deknatel | Teleflex Medical LLC | 373 |
| Corolene® | Peters Surgical | 354 |
| WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 346 |
| Surgipro II | Covidien LP | 254 |
| Surgipro ll | Covidien LP | 152 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 140 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
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.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-04-03 | Not classified | Other | Potential for sterility of product to be compromised. Suture package seals incomplete or missing. | 1332 suture packets | 2008-08-01 |
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 |
|---|---|---|---|
| P890002 | 1989-05-31 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories, Inc. |
| P820083 | 1986-08-05 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, Inc. |
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.