Safil Quick+
Safil QUI + Undy 6/0(0.7)45CM VLM10(MDDP
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 | 2015-08-16 |
| Record revised | 2024-05-08 (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 |
| Sizes | Length 45 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C1046422 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G1046441 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046610 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1046365 | Length 90.0 cm | 4 | Withdrawn |
| G1037015 | Length 250.00 cm | 12 | Withdrawn |
| B1046075 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| X1037017 | Length 250.0 cm | 4 | Withdrawn |
| G1046597 | Length 90.00 cm | 12 | Withdrawn |
| X1046236 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| G1046273 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046003 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1046140 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046131 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046234 | Length 70.00 cm | 36 | Withdrawn |
| C1046325 | Length 45.00 cm | 36 | Withdrawn |
| X1046041 | Length 70.00 cm | 4 | Withdrawn |
| X1046241 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1046651 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046143 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| X1046221 | Length 45.00 cm | 4 | Withdrawn |
| C1046597 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1037003 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046231 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046293 | Length 70.00 cm | 12 | Withdrawn |
| G1046421 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C1046657 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X1046242 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1046271 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046625 | Length 45.00 cm | 36 | Withdrawn |
| G1037018 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046060 | Length 70.00 cm | 36 | Withdrawn |
| B1037007 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| C1046838 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046711 | Length 45.00 cm | 12 | Withdrawn |
| C1046083 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046002 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| C1046224 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046515 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G1046556 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046602 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1037626 | Length 45.00 cm | 36 | Withdrawn |
| X1037020 | Length 250.00 cm | 4 | Withdrawn |
| C1046090 | Length 70.00 cm | 36 | Withdrawn |
| G1046220 | Length 45.00 cm | 12 | Withdrawn |
| C1046779 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046221 | Length 45.00 cm | 36 | Withdrawn |
| C1046630 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1037625 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1046651 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X1046530 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046054 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X1046653 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1046230 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046293 | Length 70.00 cm | 36 | Withdrawn |
| X1046142 | Length 70.0 cm | 4 | Withdrawn |
| B1046604 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| X1046595 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046237 | Length 70.00 cm | 12 | Withdrawn |
| G1046442 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| G1046422 | Length 70.00 cm | 12 | Withdrawn |
| C1046619 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C1046375 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1046653 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046208 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1046665 | Length 90.0 cm | 4 | Withdrawn |
| C1046230 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1046148 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1046663 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046410 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1046559 | Length 70.00 cm | 36 | Withdrawn |
| C1046039 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046016 | Length 70.00 cm | 36 | Withdrawn |
| C1046531 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X1046442 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| X1046042 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| X1046529 | Length 70.00 cm | 4 | Withdrawn |
| X1046018 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| X1046556 | Length 90.00 cm | 4 | Withdrawn |
| C1046241 | Length 90.00 cm | 36 | Withdrawn |
| C1046591 | Length 140.00 cm | 36 | Withdrawn |
| C1046091 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046018 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046272 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1046141 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| B1037448 | Length 70.00 cm | 24 | Withdrawn |
| B1037008 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| X1046214 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1046321 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1037444 | Length 70.00 cm | 36 | Withdrawn |
| C1046535 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X1046525 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| B1046086 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| X1046631 | Length 45.0 cm | 4 | Withdrawn |
| G1046657 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046360 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1046013 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046618 | Length 45.00 cm | 36 | Withdrawn |
| C1046013 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046320 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| B1037688 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| C1046620 | Length 45.00 cm | 36 | Withdrawn |
| G1046420 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| X1046012 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046235 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046031 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046374 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| X1046029 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046234 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046223 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046049 | Length 70.00 cm | 12 | Withdrawn |
| X1046229 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| G1046201 | Length 70.00 cm | 12 | Withdrawn |
| C1037029 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1037017 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046012 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C1046421 | Length 70.00 cm | 36 | Withdrawn |
| C1037026 | Length 70.00 cm | 36 | Withdrawn |
| C1037706 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1046273 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046001 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046755 | Length 70.00 cm | 36 | Withdrawn |
| B1046100 | Thread Material : polyglycolic acid | 24 | Withdrawn |
| C1046326 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046733 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046007 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046365 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1046732 | Length 90.00 cm | 36 | Withdrawn |
| X1046607 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| G1046031 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C1046662 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G1046090 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| G1037016 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046419 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046155 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1046557 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G1046030 | Length 70.00 cm | 12 | Withdrawn |
| C1046525 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046242 | Length 90.00 cm | 36 | Withdrawn |
| G1046227 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046400 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X1037005 | Length 45.0 cm | 4 | Withdrawn |
| C1046046 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1046180 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G1046221 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046413 | Length 45.00 cm | 36 | Withdrawn |
| X1046143 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C1046261 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X1046320 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| X1046421 | Length 70.0 cm | 4 | Withdrawn |
| C1046528 | Length 70.00 cm | 36 | Withdrawn |
| G1046012 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1046002 | Length 70.0 cm | 4 | Withdrawn |
| G1046619 | Length 45.00 cm | 12 | Withdrawn |
| C1046047 | Length 70.00 cm | 36 | Withdrawn |
| C1046004 | Length 90.00 cm | 36 | Withdrawn |
| C1037627 | Length 45.00 cm | 36 | Withdrawn |
| C1046300 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046030 | Length 70.00 cm | 36 | Withdrawn |
| G1046203 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C1046212 | Length 70.00 cm | 36 | Withdrawn |
| X1046662 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1046220 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1037028 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046595 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| G1046011 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1046092 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C1046235 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1037692 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046271 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046612 | Length 45.00 cm | 12 | Withdrawn |
| C1046488 | Length 70.00 cm | 36 | Withdrawn |
| X1046557 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046236 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| G1046271 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C1046611 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X1037446 | Length 70.0 cm | 4 | Withdrawn |
| X1046212 | Size of Thread (USP – Others) : 5/0 | 4 | Withdrawn |
| C1046529 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1037446 | Length 70.00 cm | 36 | Withdrawn |
| G1046091 | Length 70.00 cm | 12 | Withdrawn |
| X1046247 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046734 | Length 45.00 cm | 12 | Withdrawn |
| C1046631 | Length 45.00 cm | 36 | Withdrawn |
| X1046040 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046229 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C1046636 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G1046274 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1037024 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| G1046247 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| G1046311 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| X1046619 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046248 | Length 90.00 cm | 36 | Withdrawn |
| G1046530 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046594 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1046262 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G1046048 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046273 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G1046229 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C1046002 | Length 70.00 cm | 36 | Withdrawn |
| C1046049 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1046001 | Length 70.00 cm | 36 | Withdrawn |
| X1046603 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| X1037447 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| X1046203 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1037004 | Length 45.00 cm | 36 | Withdrawn |
| C1046530 | Length 70.00 cm | 36 | Withdrawn |
| C1046685 | Length 70.00 cm | 36 | Withdrawn |
| X1037445 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C1046020 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1046629 | Length 45.00 cm | 36 | Withdrawn |
| X1046597 | Length 90.0 cm | 4 | Withdrawn |
| C1046770 | Length 70.00 cm | 36 | Withdrawn |
| C1046040 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X1046661 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| C1046240 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C1046207 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C1046607 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C1046220 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046206 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1037447 | Length 70.00 cm | 36 | Withdrawn |
| G1046591 | Length 140.00 cm | 12 | Withdrawn |
| G1046652 | Length 90.00 cm | 12 | Withdrawn |
| B1037449 | Length 70.00 cm | 24 | Withdrawn |
| C1046079 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C1046454 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C1046219 | Length 45.00 cm | 36 | Withdrawn |
| X1046031 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| G1046586 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046586 | Length 90.00 cm | 36 | Withdrawn |
| C1046226 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| X1046559 | Thread Material : polyglycolic acid | 4 | Withdrawn |
| G1046653 | Length 90.00 cm | 12 | Withdrawn |
| G1046047 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C1046660 | Length 90.00 cm | 36 | Withdrawn |
| C1046665 | Length 90.00 cm | 36 | Withdrawn |
| C1046558 | Length 90.00 cm | 36 | Withdrawn |
| C1037705 | Thread Material : polyglycolic acid | 36 | Withdrawn |
| C1046019 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C1046048 | Length 70.00 cm | 36 | Withdrawn |
| G1046040 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1037694 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G1046629 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| G1046013 | Length 70.00 cm | 12 | Withdrawn |
| X1046078 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| G1046241 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046507 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G1046620 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| X1046536 | Length 45.0 cm | 4 | Withdrawn |
| G1037020 | Thread Material : polyglycolic acid | 12 | Withdrawn |
| C1046005 | Length 70.00 cm | 36 | 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 |
| 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 |
| 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.