FlexiGRAFT®
QuadLink™ (10.5 x 61 mm). Sutured quadriceps tendon construct.
6manufacturers in China registered for this device type
992catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Fujian (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | LifeNet Health, United States |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Record published | 2015-09-24 |
| Record revised | 2021-12-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Sizes | Outer diameter 3 to 200 mm; length 60 to 250 mm |
| Distribution end date | 2020-11-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FGL08570 | Length 70 mm | In distribution |
| FGLTS09571 | Length 71 mm | In distribution |
| FGL10570 | Length 70 mm | In distribution |
| FGLTS-I-11590 | Length 90 mm | In distribution |
| FGLTS-I-10566 | Length 66 mm | In distribution |
| FGL09574 | Length 74 mm | In distribution |
| FQL09062 | Outer Diameter 9 mm | In distribution |
| FGL09576 | Length 76 mm | In distribution |
| FGLTS09073 | Length 73 mm | In distribution |
| FGLTS11088 | Length 88 mm | In distribution |
| FPSST45152 | Outer Diameter 4.5 mm | In distribution |
| FGLTS-I-11589 | Length 89 mm | In distribution |
| FGL08079 | Length 79 mm | In distribution |
| FCON40160 | Length 160 mm | In distribution |
| FGL08076 | Outer Diameter 8.0 mm | In distribution |
| FGLTS-I-12082 | Length 82 mm | In distribution |
| FGLTS-I-09566 | Length 66 mm | In distribution |
| FGLTS11588 | Length 88 mm | In distribution |
| FQL09568 | Outer Diameter 9.5 mm | In distribution |
| FGLTS-I-11588 | Length 88 mm | In distribution |
| FGLTS09072 | Length 72 mm | In distribution |
| FGLTS-I-10088 | Length 88 mm | In distribution |
| FGLTS11090 | Length 90 mm | In distribution |
| FGL09068 | Outer Diameter 9.0 mm | In distribution |
| FGLTS-I-10595 | Length 95 mm | In distribution |
| FGLTS12094 | Length 94 mm | In distribution |
| FGL08068 | Outer Diameter 8.0 mm | In distribution |
| FQL10561 | Outer Diameter 10.5 mm | In distribution |
| FQL11063 | Outer Diameter 11 mm | In distribution |
| FGLTS11095 | Length 95 mm | In distribution |
| FGLTS-I-09074 | Length 74 mm | In distribution |
| FGLTS-I-10065 | Length 65 mm | In distribution |
| FGLTS-I-08565 | Length 65 mm | In distribution |
| FGLTS09066 | Length 66 mm | In distribution |
| FGLTS10572 | Length 72 mm | In distribution |
| FQL10074 | Outer Diameter 10 mm | In distribution |
| FCON40250 | Length 250 mm | In distribution |
| FDL095180 | Outer Diameter 9.5 mm | In distribution |
| FGLTS-I-11081 | Length 81 mm | In distribution |
| FGLTS08568 | Length 68 mm | In distribution |
| FGL10574 | Length 74 mm | In distribution |
| FGLTS-I-10077 | Length 77 mm | In distribution |
| FGLTS-I-10087 | Length 87 mm | In distribution |
| FGL07567 | Outer Diameter 7.5 mm | In distribution |
| FDL100180 | Outer Diameter 10 mm | In distribution |
| FGL07568 | Length 68 mm | In distribution |
| FGLTS09065 | Length 65 mm | In distribution |
| FQL10060 | Outer Diameter 10 mm | In distribution |
| FGLTS10088 | Length 88 mm | In distribution |
| FQL09571 | Outer Diameter 9.5 mm | In distribution |
| FGLTS10589 | Length 89 mm | In distribution |
| FGL07574 | Length 74 mm | In distribution |
| FGLTS-I-09577 | Length 77 mm | In distribution |
| FQL10068 | Outer Diameter 10 mm | In distribution |
| FGL09580 | Length 80 mm | In distribution |
| FGLTS-I-10569 | Length 69 mm | In distribution |
| FGLTS-I-12594 | Length 94 mm | In distribution |
| FGL10573 | Outer Diameter 10.5 mm | In distribution |
| FGLTS08574 | Length 74 mm | In distribution |
| FGL10078 | Outer Diameter 10.0 mm | In distribution |
| FDL110200 | Outer Diameter 11 mm | In distribution |
| FGL08080 | Outer Diameter 8.0 mm | In distribution |
| FDL095190 | Outer Diameter 9.5 mm | In distribution |
| FGLTS11582 | Length 82 mm | In distribution |
| FGL10560 | Length 60 mm | In distribution |
| FCON45250 | Length 250 mm | In distribution |
| FGLTS-I-11082 | Length 82 mm | In distribution |
| FGLTS-I-09582 | Length 82 mm | In distribution |
| FGLTS-I-11582 | Length 82 mm | In distribution |
| FGLTS10079 | Length 79 mm | In distribution |
| FGLTS-I-12584 | Length 84 mm | In distribution |
| FCON45200 | Length 200 mm | In distribution |
| FGLTS-I-09585 | Length 85 mm | In distribution |
| FDL105200 | Outer Diameter 10.5 mm | In distribution |
| FGLTS-I-10083 | Length 83 mm | In distribution |
| FGL07576 | Length 76 mm | In distribution |
| FGLTS11587 | Length 87 mm | In distribution |
| FGLTS12091 | Length 91 mm | In distribution |
| FGLTS10065 | Length 65 mm | In distribution |
| FGLTS11083 | Length 83 mm | In distribution |
| FCON50150 | Length 150 mm | In distribution |
| FGL09061 | Length 61 mm | In distribution |
| FGLTS-I-09072 | Length 72 mm | In distribution |
| FGL08563 | Outer Diameter 8.5 mm | In distribution |
| FGLTS12586 | Length 86 mm | In distribution |
| FGL09067 | Length 67 mm | In distribution |
| FGLTS09069 | Length 69 mm | In distribution |
| FGL10070 | Outer Diameter 10.0 mm | In distribution |
| FQL09564 | Outer Diameter 9.5 mm | In distribution |
| FGLTS09584 | Length 84 mm | In distribution |
| FGLTS-I-11587 | Length 87 mm | In distribution |
| FQL11064 | Outer Diameter 11 mm | In distribution |
| FGLTS10069 | Length 69 mm | In distribution |
| FCON45190 | Length 190 mm | In distribution |
| FCON40150 | Length 150 mm | In distribution |
| FGL10066 | Outer Diameter 10.0 mm | In distribution |
| FGLTS-I-10074 | Length 74 mm | In distribution |
| FGLTS-I-09581 | Length 81 mm | In distribution |
| FGLTS10089 | Length 89 mm | In distribution |
| FGLTS09589 | Length 89 mm | In distribution |
| FGLTS-I-10584 | Length 84 mm | In distribution |
| FQL11069 | Outer Diameter 11 mm | In distribution |
| FGLTS-I-10588 | Length 88 mm | In distribution |
| FGLTS-I-08575 | Length 75 mm | In distribution |
| FQL10073 | Outer Diameter 10 mm | In distribution |
| FGLTS-I-11595 | Length 95 mm | In distribution |
| FGLTS10574 | Length 74 mm | In distribution |
| FGL09570 | Length 70 mm | In distribution |
| FGLTS09583 | Length 83 mm | In distribution |
| FGLTS-I-10070 | Length 70 mm | In distribution |
| FQL10571 | Outer Diameter 10.5 mm | In distribution |
| FGLTS10595 | Length 95 mm | In distribution |
| FGLTS-I-11585 | Length 85 mm | In distribution |
| FGLTS-I-10574 | Length 74 mm | In distribution |
| FCONEXT170 | Length 170 mm | In distribution |
| FQL10575 | Outer Diameter 10.5 mm | In distribution |
| FGLTS10571 | Length 71 mm | In distribution |
| FPSST40158 | Length 158 mm | In distribution |
| FGL10075 | Length 75 mm | In distribution |
| FGLTS-I-10580 | Length 80 mm | In distribution |
| FCON40170 | Length 170 mm | In distribution |
| FGLTS12083 | Length 83 mm | In distribution |
| FGLTS09585 | Length 85 mm | In distribution |
| FGL09065 | Length 65 mm | In distribution |
| FGLTS11086 | Length 86 mm | In distribution |
| FGLTS12090 | Length 90 mm | In distribution |
| FGLTS-I-09572 | Length 72 mm | In distribution |
| FGL10079 | Length 79 mm | In distribution |
| FGLTS08576 | Length 76 mm | In distribution |
| FGLTS-I-12094 | Length 94 mm | In distribution |
| FGLTS-I-09590 | Length 90 mm | In distribution |
| FGLTS-I-10089 | Length 89 mm | In distribution |
| FGL08573 | Outer Diameter 8.5 mm | In distribution |
| FGLTS-I-09589 | Length 89 mm | In distribution |
| FGL10577 | Outer Diameter 10.5 mm | In distribution |
| FGLTS10578 | Length 78 mm | In distribution |
| FPSST40154 | Length 154 mm | In distribution |
| FGL09578 | Length 78 mm | In distribution |
| FGLTS12592 | Length 92 mm | In distribution |
| FGLTS-I-12582 | Length 82 mm | In distribution |
| FGLTS-I-12091 | Length 91 mm | In distribution |
| FGLTS12085 | Length 85 mm | In distribution |
| FGL10565 | Outer Diameter 10.5 mm | In distribution |
| FQL11068 | Outer Diameter 11 mm | In distribution |
| FGLTS09078 | Length 78 mm | In distribution |
| FGL07569 | Outer Diameter 7.5 mm | In distribution |
| FGLTS11089 | Length 89 mm | In distribution |
| FCON45160 | Length 160 mm | In distribution |
| FGL07579 | Outer Diameter 7.5 mm | In distribution |
| FGLTS-I-10567 | Length 67 mm | In distribution |
| FDL105215 | Outer Diameter 10.5 mm | In distribution |
| FGL10080 | Outer Diameter 10.0 mm | In distribution |
| FGL09567 | Outer Diameter 9.5 mm | In distribution |
| FGLTS-I-10592 | Length 92 mm | In distribution |
| FGLTS-I-09083 | Length 83 mm | In distribution |
| FCON45150 | Length 150 mm | In distribution |
| FGLTS-I-12583 | Length 83 mm | In distribution |
| FCON40220 | Length 220 mm | In distribution |
| FGLTS-I-10573 | Length 73 mm | In distribution |
| FGLTS-I-10572 | Length 72 mm | In distribution |
| FGLTS10091 | Length 91 mm | In distribution |
| FGL08572 | Length 72 mm | In distribution |
| FQL10569 | Outer Diameter 10.5 mm | In distribution |
| FGLTS10591 | Length 91 mm | In distribution |
| FGL07562 | Length 62 mm | In distribution |
| FDL110180 | Outer Diameter 11 mm | In distribution |
| FGL10575 | Outer Diameter 10.5 mm | In distribution |
| FGL07573 | Outer Diameter 7.5 mm | In distribution |
| FQL09565 | Outer Diameter 9.5 mm | In distribution |
| FGL09577 | Outer Diameter 9.5 mm | In distribution |
| FGL09561 | Outer Diameter 9.5 mm | In distribution |
| FDL095195 | Outer Diameter 9.5 mm | In distribution |
| FPSST40160 | Length 160 mm | In distribution |
| FDL095215 | Outer Diameter 9.5 mm | In distribution |
| FGL10572 | Length 72 mm | In distribution |
| FCON45230 | Length 230 mm | In distribution |
| FGL08565 | Outer Diameter 8.5 mm | In distribution |
| FCON45220 | Length 220 mm | In distribution |
| FGLTS-I-12085 | Length 85 mm | In distribution |
| FGLTS11085 | Length 85 mm | In distribution |
| FGLTS10068 | Length 68 mm | In distribution |
| FGL07577 | Outer Diameter 7.5 mm | In distribution |
| FQL09066 | Outer Diameter 9 mm | In distribution |
| FGLTS-I-09573 | Length 73 mm | In distribution |
| FGL08075 | Length 75 mm | In distribution |
| FGLTS-I-09569 | Length 69 mm | In distribution |
| FGL09571 | Outer Diameter 9.5 mm | In distribution |
| FGLTS-I-10581 | Length 81 mm | In distribution |
| FCON40180 | Length 180 mm | In distribution |
| FDL110210 | Outer Diameter 11 mm | In distribution |
| FCONEXT180 | Length 180 mm | In distribution |
| FGL10568 | Length 68 mm | In distribution |
| FGL08576 | Length 76 mm | In distribution |
| FGLTS-I-12087 | Length 87 mm | In distribution |
| FGL07578 | Length 78 mm | In distribution |
| FGLTS-I-10076 | Length 76 mm | In distribution |
| FCON50190 | Length 190 mm | In distribution |
| FGL09070 | Outer Diameter 9.0 mm | In distribution |
| FGL08578 | Length 78 mm | In distribution |
| FDL100215 | Outer Diameter 10 mm | In distribution |
| FPSST45154 | Outer Diameter 4.5 mm | In distribution |
| FCON50250 | Length 250 mm | In distribution |
| FGL07565 | Outer Diameter 7.5 mm | In distribution |
| FGL10074 | Outer Diameter 10.0 mm | In distribution |
| FGLTS12594 | Length 94 mm | In distribution |
| FGLTS-I-10084 | Length 84 mm | In distribution |
| FPSST45158 | Outer Diameter 4.5 mm | In distribution |
| FGLTS-I-10095 | Length 95 mm | In distribution |
| FGLTS-I-09579 | Length 79 mm | In distribution |
| FGLTS-I-10078 | Length 78 mm | In distribution |
| FPSST45150 | Outer Diameter 4.5 mm | In distribution |
| FGL09575 | Outer Diameter 9.5 mm | In distribution |
| FGLTS-I-08569 | Length 69 mm | In distribution |
| FGLTS10095 | Length 95 mm | In distribution |
| FGLTS-I-12090 | Length 90 mm | In distribution |
| FGLTS-I-12080 | Length 80 mm | In distribution |
| FGLTS11080 | Length 80 mm | In distribution |
| FGLTS09089 | Length 89 mm | In distribution |
| FGLTS09067 | Length 67 mm | In distribution |
| FGLTS10573 | Length 73 mm | In distribution |
| FGLTS09573 | Length 73 mm | In distribution |
| FGLTS-I-09073 | Length 73 mm | In distribution |
| FGL07570 | Length 70 mm | In distribution |
| FGLTS11580 | Length 80 mm | In distribution |
| FGLTS-I-09586 | Length 86 mm | In distribution |
| FGLTS10576 | Length 76 mm | In distribution |
| FDL110195 | Outer Diameter 11 mm | In distribution |
| FGLTS-I-11086 | Length 86 mm | In distribution |
| FGLTS10582 | Length 82 mm | In distribution |
| FGLTS10066 | Length 66 mm | In distribution |
| FGL09075 | Length 75 mm | In distribution |
| FGLTS-I-09085 | Length 85 mm | In distribution |
| FGLTS12082 | Length 82 mm | In distribution |
| FGL10571 | Outer Diameter 10.5 mm | In distribution |
| FGLTS-I-10093 | Length 93 mm | In distribution |
| FGL08560 | Length 60 mm | In distribution |
| FGLTS09076 | Length 76 mm | In distribution |
| FQL09573 | Outer Diameter 9.5 mm | In distribution |
| FQL09572 | Outer Diameter 9.5 mm | In distribution |
| FGLTS-I-12093 | Length 93 mm | In distribution |
| FGLTS10584 | Length 84 mm | In distribution |
| FGLTS11593 | Length 93 mm | In distribution |
| FDL100205 | Outer Diameter 10 mm | In distribution |
| FGLTS12089 | Length 89 mm | In distribution |
| FGLTS10579 | Length 79 mm | In distribution |
| FGLTS-I-10586 | Length 86 mm | In distribution |
| FCON40230 | Length 230 mm | In distribution |
| FGL10060 | Outer Diameter 10.0 mm | In distribution |
| FDL100210 | Outer Diameter 10 mm | In distribution |
| FQL09067 | Outer Diameter 9 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| DemeBOND | Demetech Corp. | 939 |
| Ti-Cron | Covidien LP | 482 |
| HS FIber | Riverpoint Medical LLC | 413 |
| Ethibond Excel | Ethicon, Inc. | 383 |
| Arthrex® | Arthrex, Inc. | 307 |
| Dagrofil | B Braun Surgical SA | 195 |
| WEGO-Polyester Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 175 |
| Cardioxyl ® | Peters Surgical | 162 |
| Silkam | B Braun Surgical SA | 150 |
| HyperSuture | Threadstone LLC | 137 |
Showing 12 of 275. All products under Suture, Nonabsorbable, Synthetic, Polyethylene
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 |
|---|---|---|---|
| N16374 | 1986-01-23 | PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S | Ethicon, Inc. |
| P810028 | 1984-12-17 | DEKLENE(TM) | Deknatel, Inc. |
| N17825 | 1981-09-24 | SURGILENE | 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.