Novosyn
Novosyn Violet 2 (5) 90CM HR37SS (M) DDP
4manufacturers in China registered for this device type
2,286catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | B Braun Surgical SA |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Record published | 2015-11-12 |
| Record revised | 2026-03-31 (version 18) |
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 | Carton of 30, carton of 60 |
| Sizes | Length 15 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B0068655 | Length 90.00 cm | 24 | Withdrawn |
| C0068465 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0069076 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| G0068496 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| C0068993 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068194 | Length 120.00 cm | 36 | Withdrawn |
| G0068242 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0069310 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| M0088042 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| B0069105 | Size of Thread (USP – Others) : 2 | 24 | Withdrawn |
| C0069705 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| M0088266 | Size of Thread (USP – Others) : 0 | 6 | Withdrawn |
| X0068151 | Length 70.00 cm | 4 | Withdrawn |
| C0069818 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0069013 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068583 | Length 90.00 cm | 36 | Withdrawn |
| C0068745 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0069461 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068398 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068506 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0068126 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0068343 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| G0069591 | Length 45.00 cm | 12 | Withdrawn |
| C0088921 | Length 45.00 cm | 36 | Withdrawn |
| X0068507 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068229 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| X0069096 | Length 70.00 cm | 4 | Withdrawn |
| B0058568 | Length 60.00 cm | 24 | Withdrawn |
| B0068675 | Size of Thread (USP – Others) : 2 | 24 | Withdrawn |
| G0088770 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| X0068043 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| X0069618 | Length 45.00 cm | 4 | Withdrawn |
| C0068417 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0068181 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| M0089157 | Length 45.00 cm | 6 | Withdrawn |
| C0068471 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069234 | Length 70.00 cm | 36 | Withdrawn |
| M0088256 | Length 70.00 cm | 6 | Withdrawn |
| G0069530 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0069474 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| M0088230 | Length 70.00 cm | 6 | Withdrawn |
| X0069297 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068524 | Length 90.00 cm | 36 | Withdrawn |
| C0069008 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X0068162 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C0068756 | Length 120.00 cm | 36 | Withdrawn |
| G0068346 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| M0089117 | Size of Thread (USP – Others) : 2/0 | 6 | Withdrawn |
| G0068142 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C0088316 | Length 70.00 cm | 36 | Withdrawn |
| G0068562 | Length 90.00 cm | 12 | Withdrawn |
| C0068234 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0089742 | Length 45.00 cm | 36 | Withdrawn |
| C0068203 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| X0069734 | Length 45.00 cm | 4 | Withdrawn |
| B0068872 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| G0069421 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068258 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0068877 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069657 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| B0059670 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| C0068897 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069089 | Length 70.00 cm | 36 | Withdrawn |
| C0069618 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| M0088243 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| G0058405 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0069437 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| M0088037 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| B0068680 | Size of Thread (USP – Others) : 2 | 24 | Withdrawn |
| C0068637 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0069562 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068163 | Length 70.00 cm | 36 | Withdrawn |
| C0068907 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0068586 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068450 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068282 | Length 70.00 cm | 36 | Withdrawn |
| G0069236 | Length 70.00 cm | 12 | Withdrawn |
| G0068488 | Size of Thread (USP – Others) : 2 | 12 | Withdrawn |
| X0069267 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| C0088901 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068060 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069289 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| M0089138 | Size of Thread (USP – Others) : 3/0 | 6 | Withdrawn |
| G0058717 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| C0068978 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0088335 | Length 45.00 cm | 36 | Withdrawn |
| X0088791 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068205 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069197 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068426 | Length 70.00 cm | 36 | Withdrawn |
| C0069596 | Length 90.00 cm | 36 | Withdrawn |
| C0068544 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0068553 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068218 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C0068242 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| B0088715 | Length 70.00 cm | 24 | Withdrawn |
| G0068930 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068169 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| X0068221 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C0069455 | Length 140.00 cm | 36 | Withdrawn |
| G0058407 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| X0069230 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| X0068046 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| M0088111 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| C0068160 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0088790 | Length 45.00 cm | 36 | Withdrawn |
| C0069422 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0068213 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| X0068093 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068972 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0068008 | Length 70.00 cm | 12 | Withdrawn |
| X0068002 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| M0068153 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| C0069206 | Length 45.00 cm | 36 | Withdrawn |
| B0058709 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| C0068294 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0068732 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| X0068591 | Length 90.00 cm | 4 | Withdrawn |
| B0088911 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0068360 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0088912 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| C0068286 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068300 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| X0069290 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| G0068957 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| B0088632 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| B0089703 | Length 45.00 cm | 24 | Withdrawn |
| X0069430 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| B0068598 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| X0068220 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| C0088910 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X0068538 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| X0068592 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| M0088130 | Length 45.00 cm | 6 | Withdrawn |
| C0069349 | Length 70.00 cm | 36 | Withdrawn |
| C0088801 | Length 45.00 cm | 36 | Withdrawn |
| C0068262 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| B0069712 | Length 45.00 cm | 24 | Withdrawn |
| C0069524 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0069620 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| M0088110 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| X0068782 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C0069195 | Length 70.00 cm | 36 | Withdrawn |
| C0059666 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X0068236 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| C0068528 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068716 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0068880 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0069265 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| G0068987 | Length 150.00 cm | 12 | Withdrawn |
| X0069327 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068425 | Length 70.00 cm | 36 | Withdrawn |
| C0068538 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0068047 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068104 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069198 | Length 70.00 cm | 36 | Withdrawn |
| C0068653 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G0058209 | Length 140.00 cm | 12 | Withdrawn |
| C0068109 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| B0068873 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0068865 | Length 70.00 cm | 36 | Withdrawn |
| G0068711 | Length 45.00 cm | 12 | Withdrawn |
| C0068250 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0068766 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| M0088210 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| C0069352 | Length 70.00 cm | 36 | Withdrawn |
| M0089819 | Size of Thread (USP – Others) : 2/0 | 6 | Withdrawn |
| G0068013 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| G0068621 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| G0068588 | Size of Thread (USP – Others) : 2 | 12 | Withdrawn |
| X0068622 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C0069047 | Length 70.00 cm | 36 | Withdrawn |
| G0068002 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0069865 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068019 | Length 45.00 cm | 36 | Withdrawn |
| C0069629 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0068445 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0068093 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068904 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068934 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0058064 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0058626 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X0069208 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068093 | Length 70.00 cm | 36 | Withdrawn |
| G0068568 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| G0068442 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| B0088306 | Length 90.00 cm | 24 | Withdrawn |
| C0068039 | Length 70.00 cm | 36 | Withdrawn |
| X0068466 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| X0069090 | Length 70.00 cm | 4 | Withdrawn |
| C0088769 | Length 45.00 cm | 36 | Withdrawn |
| G0068796 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| G0068531 | Length 45.00 cm | 12 | Withdrawn |
| C0068387 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0068008 | Length 70.00 cm | 36 | Withdrawn |
| C0069042 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| G0069599 | Length 45.00 cm | 12 | Withdrawn |
| M0088214 | Size of Thread (USP – Others) : 1 | 6 | Withdrawn |
| C0059616 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C0068758 | Length 45.00 cm | 36 | Withdrawn |
| C0069267 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069050 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0088647 | Length 70.00 cm | 36 | Withdrawn |
| X0068213 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| X0068824 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C0069253 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069725 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| B0088785 | Size of Thread (USP – Others) : 2/0 | 24 | Withdrawn |
| B0088670 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| C0068007 | Length 70.00 cm | 36 | Withdrawn |
| C0068412 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X0058670 | Size of Thread (USP – Others) : 2 | 4 | Withdrawn |
| C0068055 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| B0089718 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| C0068042 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0088640 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0068641 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0068971 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0089794 | Length 45.00 cm | 36 | Withdrawn |
| C0068463 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| B0089696 | Thread Material : PGLA (90/10) | 24 | Withdrawn |
| C0068508 | Length 70.00 cm | 36 | Withdrawn |
| M0088030 | Thread Material : PGLA (90/10) | 6 | Withdrawn |
| X0069331 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0068690 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0068384 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0068572 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0069221 | Length 45.00 cm | 36 | Withdrawn |
| C0069441 | Length 70.00 cm | 36 | Withdrawn |
| G0068450 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068618 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0068777 | Length 120.00 cm | 36 | Withdrawn |
| X0058669 | Length 45.00 cm | 4 | Withdrawn |
| X0069013 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| G0068092 | Thread Material : PGLA (90/10) | 12 | Withdrawn |
| C0068444 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0068545 | Length 90.00 cm | 36 | Withdrawn |
| C0068323 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| M0088191 | Size of Thread (USP – Others) : 4/0 | 6 | Withdrawn |
| X0068012 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C0069758 | Length 70.00 cm | 36 | Withdrawn |
| C0068829 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| X0069440 | Thread Material : PGLA (90/10) | 4 | Withdrawn |
| C0069322 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| C0069408 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| B0088693 | Size of Thread (USP – Others) : 2 | 24 | Withdrawn |
| C0058407 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X0068044 | Length 70.00 cm | 4 | Withdrawn |
| C0068784 | Thread Material : PGLA (90/10) | 36 | Withdrawn |
| M0088151 | Size of Thread (USP – Others) : 0 | 6 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 319 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
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 |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | Davis & Geck, 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.