Optilene
Optilene 7/0(0,5)75CM 2XDR8B US175MCVRCP
3manufacturers in China registered for this device type
1,110catalogue 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 | B Braun Surgical SA |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Record published | 2015-08-18 |
| Record revised | 2026-03-27 (version 16) |
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 |
| Sizes | Length 5 to 240 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C3090903 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C3090042 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090909 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C3090630 | Length 45.0 cm | 36 | Withdrawn |
| C3095654 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095569 | Length 75.00 cm | 36 | Withdrawn |
| G3090880 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C3090151 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095276 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3096141 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| B3095450 | Length 200.0 cm | 24 | Withdrawn |
| C3095244 | Length 45.00 cm | 36 | Withdrawn |
| C3090135 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| G3096100 | Length 13.00 cm | 12 | Withdrawn |
| C3090620 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3095132 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C3095347 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G3090741 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| G3090980 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| X3095921 | Thread Material : polypropylene with polyethylen | 4 | Withdrawn |
| G3090168 | Length 75.00 cm | 12 | Withdrawn |
| C3090477 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090373 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3095636 | Length 90.00 cm | 36 | Withdrawn |
| C3090538 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C3090716 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C3090066 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G3090219 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090603 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| X3095906 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C3090934 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C3090259 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C3090276 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3096104 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090131 | Length 75.00 cm | 36 | Withdrawn |
| C3090853 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090047 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095557 | Length 90.00 cm | 36 | Withdrawn |
| C3095442 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C3090995 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C3095431 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G3090814 | Length 45.00 cm | 12 | Withdrawn |
| C3095805 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090669 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090428 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C3096007 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095525 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G3090822 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3090785 | Length 75.0 cm | 12 | Withdrawn |
| G3090662 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| C3090275 | Length 75.0 cm | 36 | Withdrawn |
| G3095050 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3095313 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3090146 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090421 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X3090502 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| G3090401 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3096101 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| C3090427 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090617 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C3090040 | Length 75.00 cm | 36 | Withdrawn |
| G3095154 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| G3095793 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| C3095059 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090317 | Length 100.0 cm | 36 | Withdrawn |
| G3090888 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| X3090880 | Thread Material : polypropylene with polyethylen | 4 | Withdrawn |
| C3095268 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095574 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090615 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090529 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3096169 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C3090800 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C3095737 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090266 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C3095826 | Length 45.00 cm | 36 | Withdrawn |
| G3090908 | Length 90.00 cm | 12 | Withdrawn |
| G3090694 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3095701 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095658 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C3090994 | Length 20.00 cm | 36 | Withdrawn |
| X3090012 | Length 75.00 cm | 4 | Withdrawn |
| X3090977 | Length 90.00 cm | 4 | Withdrawn |
| C3090525 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C3090907 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G3096127 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090406 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C3095456 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C3090860 | Length 75.00 cm | 36 | Withdrawn |
| G3090248 | Length 75.0 cm | 12 | Withdrawn |
| G3095043 | Length 75.00 cm | 12 | Withdrawn |
| C3095251 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090595 | Length 15.00 cm | 12 | Withdrawn |
| C3095036 | Length 45.0 cm | 36 | Withdrawn |
| G3090589 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| G3095307 | Length 12.0 cm | 12 | Withdrawn |
| X3090581 | Length 90.00 cm | 4 | Withdrawn |
| C3090866 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X3090029 | Thread Material : polypropylene with polyethylen | 4 | Withdrawn |
| C3095835 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090642 | Length 90.00 cm | 12 | Withdrawn |
| C3090264 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G3095543 | Length 75.0 cm | 12 | Withdrawn |
| X3090040 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| G3090394 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3095906 | Length 75.00 cm | 36 | Withdrawn |
| C3090676 | Length 45.0 cm | 36 | Withdrawn |
| G3090211 | Length 45.0 cm | 12 | Withdrawn |
| C3090667 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C3090888 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090099 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C3095816 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090590 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3095697 | Length 75.0 cm | 36 | Withdrawn |
| C3090077 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C3090692 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C3095349 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095710 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X3090725 | Length 75.00 cm | 4 | Withdrawn |
| C3095531 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C3095195 | Length 75.00 cm | 36 | Withdrawn |
| X3090783 | Length 15.00 cm | 4 | Withdrawn |
| C3090145 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G3095216 | Length 45.00 cm | 12 | Withdrawn |
| C3090678 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090084 | Length 60.00 cm | 36 | Withdrawn |
| C3095608 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090973 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090246 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090474 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C3095700 | Length 45.0 cm | 36 | Withdrawn |
| C3096022 | Length 75.0 cm | 36 | Withdrawn |
| G3095168 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3090040 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C3090544 | Length 60.00 cm | 36 | Withdrawn |
| X3095607 | Thread Material : polypropylene with polyethylen | 4 | Withdrawn |
| G3090179 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090472 | Length 75.0 cm | 36 | Withdrawn |
| C3095414 | Length 90.0 cm | 36 | Withdrawn |
| C3095146 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095417 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090869 | Length 75.00 cm | 36 | Withdrawn |
| X3090014 | Length 75.00 cm | 4 | Withdrawn |
| C3095449 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C3095819 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| G3090620 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090972 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090519 | Length 75.0 cm | 12 | Withdrawn |
| C3090728 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G3095429 | Length 75.00 cm | 12 | Withdrawn |
| C3090254 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G3090832 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| G3090594 | Size of Thread (USP – Others) : 9/0 | 12 | Withdrawn |
| C3095526 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| X3090670 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C3095215 | Length 90.00 cm | 36 | Withdrawn |
| C3090577 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C3095048 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090581 | Length 90.00 cm | 12 | Withdrawn |
| C3096173 | Length 75.00 cm | 36 | Withdrawn |
| C3090703 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090287 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3095169 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090990 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G3090630 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3095751 | Length 90.0 cm | 12 | Withdrawn |
| C3091010 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090522 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C3090205 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X3090529 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| X3090546 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C3095110 | Length 60.00 cm | 36 | Withdrawn |
| C3095027 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C3090570 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090758 | Length 60.0 cm | 12 | Withdrawn |
| C3095150 | Length 120.00 cm | 36 | Withdrawn |
| X3090004 | Length 75.00 cm | 4 | Withdrawn |
| C3096111 | Length 45.00 cm | 36 | Withdrawn |
| X3090953 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C3095306 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C3095825 | Length 90.00 cm | 36 | Withdrawn |
| G3095277 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C3095870 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| G3095133 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| G3095760 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C3090516 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C3095613 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090053 | Length 75.0 cm | 36 | Withdrawn |
| G3095176 | Length 75.00 cm | 12 | Withdrawn |
| C3090979 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095633 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090100 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C3090725 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C3095301 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090882 | Length 75.0 cm | 36 | Withdrawn |
| G3090255 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3095097 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095896 | Length 60.00 cm | 36 | Withdrawn |
| C3090256 | Length 75.0 cm | 36 | Withdrawn |
| X3090042 | Thread Material : polypropylene with polyethylen | 4 | Withdrawn |
| C3090580 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090978 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C3090512 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090776 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3096145 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C3090913 | Length 75.00 cm | 36 | Withdrawn |
| X3095825 | Thread Material : polypropylene with polyethylen | 4 | Withdrawn |
| G3090903 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C3090086 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| X3090594 | Size of Thread (USP – Others) : 9/0 | 4 | Withdrawn |
| C3095559 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090520 | Length 75.0 cm | 12 | Withdrawn |
| G3090212 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| C3090546 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G3095979 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| G3090024 | Size of Thread (USP – Others) : 10/0 | 12 | Withdrawn |
| B3095578 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C3090247 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090656 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G3090016 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| G3095128 | Length 75.00 cm | 12 | Withdrawn |
| C3095495 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090132 | Length 75.0 cm | 36 | Withdrawn |
| G3095149 | Length 45.0 cm | 12 | Withdrawn |
| X3090715 | Length 60.00 cm | 4 | Withdrawn |
| C3095025 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090029 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| G3090883 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3090172 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| G3090207 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| C3090093 | Length 75.0 cm | 36 | Withdrawn |
| G3090363 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C3090211 | Length 45.0 cm | 36 | Withdrawn |
| X3090671 | Length 75.00 cm | 4 | Withdrawn |
| C3090711 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095103 | Length 90.00 cm | 36 | Withdrawn |
| G3090369 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| C3095219 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090803 | Length 45.00 cm | 36 | Withdrawn |
| C3090281 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3090808 | Length 75.00 cm | 36 | Withdrawn |
| C3095351 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095124 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G3095162 | Thread Material : polypropylene with polyethylen | 12 | Withdrawn |
| G3090357 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C3090219 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G3095589 | Size of Thread (USP – Others) : 6/0 | 12 | Withdrawn |
| C3090052 | Thread Material : polypropylene with polyethylen | 36 | Withdrawn |
| C3095377 | Length 90.00 cm | 36 | Withdrawn |
| C3090269 | Length 75.0 cm | 36 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| Premilene | B Braun Surgical SA | 1,247 |
| 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 |
| Gore-TEX Suture | W. L. Gore & Associates, Inc. | 113 |
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.