Safil
Safil Violet 0 (3.5) 4X70CM HR37S (M) TO
4manufacturers in China registered for this device type
1,613catalogue 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 | 2015-08-17 |
| Record revised | 2024-05-08 (version 17) |
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 8 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C1078795 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X1078768 | Size of Thread (USP – Others) : 2 | 4 | Withdrawn |
| C1048003 | Length 70.00 cm | 36 | Withdrawn |
| X1078698 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1078696 | Length 70.00 cm | 36 | Withdrawn |
| X1049364 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1049148 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| M1078164 | Length 45.00 cm | 6 | Withdrawn |
| C1038064 | Length 90.00 cm | 36 | Withdrawn |
| X1048597 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C1048590 | Length 90.00 cm | 36 | Withdrawn |
| G1048290 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1048291 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| G1048736 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1048864 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1038180 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1049665 | Size of Thread (USP – Others) : 2 | 4 | Withdrawn |
| C1048256 | Length 70.00 cm | 36 | Withdrawn |
| X1048044 | Length 70.0 cm | 4 | Withdrawn |
| C1048580 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1078836 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1039630 | Length 45.00 cm | 36 | Withdrawn |
| X1048203 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C1048781 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1038719 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C1049670 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048241 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048502 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048956 | Length 90.00 cm | 36 | Withdrawn |
| C1048312 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| B1039669 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| X1049620 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1038630 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048097 | Length 70.00 cm | 36 | Withdrawn |
| G1038630 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1048467 | Length 90.00 cm | 36 | Withdrawn |
| X1049441 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048987 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1048664 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1049735 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1049090 | Length 70.00 cm | 4 | Withdrawn |
| X1049530 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048043 | Length 70.00 cm | 36 | Withdrawn |
| C1078770 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1048538 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048011 | Length 70.00 cm | 36 | Withdrawn |
| C1048393 | Length 70.00 cm | 36 | Withdrawn |
| B1078767 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| G1048146 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| G1048920 | Length 45.00 cm | 12 | Withdrawn |
| G1048598 | Length 90.00 cm | 12 | Withdrawn |
| G1048253 | Length 70.00 cm | 12 | Withdrawn |
| X1048393 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C1048785 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1078788 | Size of Thread (USP – Others) : 2 | 12 | Withdrawn |
| X1048491 | Length 70.00 cm | 4 | Withdrawn |
| C1048089 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X1049630 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1049524 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1048343 | Length 70.00 cm | 4 | Withdrawn |
| G1038666 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1049562 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048367 | Length 120.00 cm | 36 | Withdrawn |
| C1048070 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| C1048562 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1048935 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1049449 | Length 90.00 cm | 36 | Withdrawn |
| C1048853 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X1078691 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1048542 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| C1049742 | Length 45.00 cm | 36 | Withdrawn |
| G1048003 | Length 70.00 cm | 12 | Withdrawn |
| X1048061 | Length 70.00 cm | 4 | Withdrawn |
| X1048219 | Length 45.00 cm | 4 | Withdrawn |
| C1048655 | Length 90.00 cm | 36 | Withdrawn |
| G1038410 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1049407 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1048533 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| X1048243 | Length 70.0 cm | 4 | Withdrawn |
| B1038706 | Length 150.00 cm | 24 | Withdrawn |
| X1048230 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C1049055 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1049327 | Length 70.00 cm | 36 | Withdrawn |
| X1048234 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1049247 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048508 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C1049607 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G1048600 | Length 8.00 cm | 12 | Withdrawn |
| X1048314 | Length 70.00 cm | 4 | Withdrawn |
| G1048037 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| C1049008 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G1048092 | Length 70.00 cm | 12 | Withdrawn |
| B1048614 | Length 90.00 cm | 24 | Withdrawn |
| C1039625 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1049620 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1048966 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1049451 | Length 70.00 cm | 4 | Withdrawn |
| C1048604 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G1048206 | Length 45.00 cm | 12 | Withdrawn |
| X1048341 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| X1048173 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C1048462 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1048874 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048948 | Length 70.00 cm | 36 | Withdrawn |
| X1078668 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| B1048380 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C1048317 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048107 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048619 | Length 90.00 cm | 36 | Withdrawn |
| C1049715 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G1048741 | Length 45.00 cm | 12 | Withdrawn |
| C1048685 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G1048447 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| B1078698 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| C1048585 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048827 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1048264 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C1039627 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1049237 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1049716 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X1048425 | Length 70.00 cm | 4 | Withdrawn |
| X1049294 | Length 90.00 cm | 4 | Withdrawn |
| C1048331 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1048494 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1078630 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| G1048241 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| X1049528 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C1048103 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G1048266 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1048101 | Length 45.00 cm | 4 | Withdrawn |
| C1048631 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048247 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1048498 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1049433 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G1048043 | Length 70.00 cm | 12 | Withdrawn |
| X1048557 | Length 90.00 cm | 4 | Withdrawn |
| C1049598 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1039407 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1048946 | Length 70.00 cm | 36 | Withdrawn |
| C1048496 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X1048204 | Length 45.00 cm | 4 | Withdrawn |
| X1038667 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| G1048585 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1078614 | Length 70.00 cm | 4 | Withdrawn |
| C1048044 | Length 70.00 cm | 36 | Withdrawn |
| C1048473 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1049234 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1048652 | Length 90.00 cm | 12 | Withdrawn |
| G1038670 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1049525 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1049421 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1048768 | Length 30.00 cm | 12 | Withdrawn |
| X1048170 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C1049529 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1038716 | Length 250.00 cm | 12 | Withdrawn |
| X1078787 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048754 | Length 20.00 cm | 36 | Withdrawn |
| C1049400 | Length 70.00 cm | 36 | Withdrawn |
| C1048569 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1048090 | Length 70.00 cm | 12 | Withdrawn |
| X1049431 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048096 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048102 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1049662 | Length 90.00 cm | 4 | Withdrawn |
| C1048094 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1048430 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1038649 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C1078716 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1038210 | Size of Thread (USP – Others) : 2 | 12 | Withdrawn |
| G1048341 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C1049528 | Length 70.00 cm | 36 | Withdrawn |
| C1038050 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048543 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1048723 | Length 70.00 cm | 36 | Withdrawn |
| C1049089 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1049636 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X1049248 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| X1048585 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048865 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048549 | Length 70.00 cm | 36 | Withdrawn |
| C1049818 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1048549 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| X1049444 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048551 | Length 90.00 cm | 36 | Withdrawn |
| G1049593 | Length 45.00 cm | 12 | Withdrawn |
| X1048089 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| G1048591 | Length 90.00 cm | 12 | Withdrawn |
| X1048561 | Length 90.00 cm | 4 | Withdrawn |
| X1048514 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048426 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X1048553 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C1048162 | Length 45.00 cm | 36 | Withdrawn |
| C1048595 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| B1038449 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C1048447 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1049041 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G1049221 | Length 45.00 cm | 12 | Withdrawn |
| C1048012 | Length 70.00 cm | 36 | Withdrawn |
| C1048052 | Length 70.00 cm | 36 | Withdrawn |
| G1048297 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1048589 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X1048226 | Length 45.0 cm | 4 | Withdrawn |
| G1048041 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C1049561 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1048967 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1048904 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X1048563 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048934 | Length 70.00 cm | 36 | Withdrawn |
| C1048169 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048165 | Length 70.00 cm | 36 | Withdrawn |
| C1049195 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1049362 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1048560 | Length 90.00 cm | 4 | Withdrawn |
| G1048631 | Length 45.00 cm | 12 | Withdrawn |
| C1049557 | Length 90.00 cm | 36 | Withdrawn |
| C1049303 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| B1038649 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C1038183 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048391 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| X1048956 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048650 | Length 90.00 cm | 36 | Withdrawn |
| X1048462 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1048755 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| B1048918 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| C1048587 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| B1048605 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C1048049 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1078762 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| G1049440 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C1049058 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048353 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1048417 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C1048907 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1048865 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| X1048473 | Size of Thread (USP – Others) : 2 | 4 | Withdrawn |
| G1048448 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| B1078670 | Length 70.00 cm | 24 | Withdrawn |
| X1048651 | Length 90.00 cm | 4 | Withdrawn |
| C1049098 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1048616 | Length 30.00 cm | 12 | Withdrawn |
| C1048278 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048653 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| X1048497 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1078691 | Length 70.00 cm | 12 | Withdrawn |
| C1048265 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1048203 | Length 45.00 cm | 36 | Withdrawn |
| G1048620 | Size of Thread (USP – Others) : 8/0 | 12 | Withdrawn |
| C1048498 | Length 90.00 cm | 36 | Withdrawn |
| C1049096 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| B1078793 | Length 45.00 cm | 24 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| 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.