DeRoyal
Suture Prolene Blue C-1 SZ 5-04-24 IN
3manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2019-11-09 |
| Record revised | 2026-04-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 99-0222 | In distribution | |
| 99-0214 | In distribution | |
| 99-0221 | 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
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.