Silkam
Silkam Black 7/0 (0.5) 45CM 2XDSMP11 (M)
6manufacturers in China registered for this device type
150catalogue 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 | B Braun Surgical SA |
|---|---|
| FDA product code | GAT |
| Device type | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5000 |
| Record published | 2015-08-20 |
| 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 45 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| G0763145 | Thread Material : silk | 12 | Withdrawn |
| B0760307 | Size of Thread (USP – Others) : 3/0 | 24 | Withdrawn |
| G0764230 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| G0765554 | Length 75.00 cm | 12 | Withdrawn |
| C0732354 | Length 45.00 cm | 36 | Withdrawn |
| C0766394 | Length 75.00 cm | 36 | Withdrawn |
| C0761476 | Thread Material : silk | 36 | Withdrawn |
| C0766372 | Length 45.00 cm | 36 | Withdrawn |
| C0762156 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0761460 | Length 75.00 cm | 36 | Withdrawn |
| C0762334 | Length 75.00 cm | 36 | Withdrawn |
| C0766506 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0765074 | Length 75.00 cm | 12 | Withdrawn |
| G0230286 | Length 250.00 cm | 12 | Withdrawn |
| C0764094 | Thread Material : silk | 36 | Withdrawn |
| G0760308 | Thread Material : silk | 12 | Withdrawn |
| G0263877 | Thread Material : silk | 12 | Withdrawn |
| G0763412 | Length 75.00 cm | 12 | Withdrawn |
| B0263850 | Size of Thread (USP – Others) : 3/0 | 24 | Withdrawn |
| B0762113 | Size of Thread (USP – Others) : 6/0 | 24 | Withdrawn |
| G0265160 | Thread Material : silk | 12 | Withdrawn |
| C0760285 | Thread Material : silk | 36 | Withdrawn |
| G0760294 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C0766262 | Thread Material : silk | 36 | Withdrawn |
| C0765203 | Thread Material : silk | 36 | Withdrawn |
| G0768758 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| C0284866 | Thread Material : silk | 36 | Withdrawn |
| C0732079 | Length 45.00 cm | 36 | Withdrawn |
| C0764612 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0767220 | Length 75.00 cm | 36 | Withdrawn |
| G0760625 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| B0762202 | Size of Thread (USP – Others) : 4/0 | 24 | Withdrawn |
| C0763411 | Thread Material : silk | 36 | Withdrawn |
| B0266507 | Thread Material : silk | 24 | Withdrawn |
| C0768260 | Thread Material : silk | 36 | Withdrawn |
| B0264679 | Length 75.00 cm | 24 | Withdrawn |
| C0760952 | Length 75.00 cm | 36 | Withdrawn |
| B0762067 | Thread Material : silk | 24 | Withdrawn |
| B0266892 | Length 45.00 cm | 24 | Withdrawn |
| G0760154 | Thread Material : silk | 12 | Withdrawn |
| G0230260 | Size of Thread (USP – Others) : 2 | 12 | Withdrawn |
| G0265152 | Length 75.00 cm | 12 | Withdrawn |
| C0764184 | Thread Material : silk | 36 | Withdrawn |
| B0263907 | Length 60.00 cm | 24 | Withdrawn |
| C0761613 | Thread Material : silk | 36 | Withdrawn |
| G0263680 | Length 60.00 cm | 12 | Withdrawn |
| G0764990 | Length 100.00 cm | 12 | Withdrawn |
| C0760235 | Thread Material : silk | 36 | Withdrawn |
| C0284858 | Length 60.00 cm | 36 | Withdrawn |
| C0765805 | Thread Material : silk | 36 | Withdrawn |
| G0766380 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| G0763218 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0765117 | Length 45.00 cm | 36 | Withdrawn |
| C0764817 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| B0284890 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| B0760129 | Size of Thread (USP – Others) : 5/0 | 24 | Withdrawn |
| G0764690 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| B0266698 | Length 45.00 cm | 24 | Withdrawn |
| B0266868 | Length 45.00 cm | 24 | Withdrawn |
| C0763217 | Thread Material : silk | 36 | Withdrawn |
| C0764167 | Thread Material : silk | 36 | Withdrawn |
| B0266876 | Thread Material : silk | 24 | Withdrawn |
| C0762270 | Length 45.00 cm | 36 | Withdrawn |
| B0284904 | Length 60.00 cm | 24 | Withdrawn |
| C0766390 | Thread Material : silk | 36 | Withdrawn |
| C0765024 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| B0263877 | Thread Material : silk | 24 | Withdrawn |
| C0764064 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0730010 | Thread Material : silk | 36 | Withdrawn |
| G0265179 | Thread Material : silk | 12 | Withdrawn |
| G0763137 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| B0764762 | Length 100.00 cm | 24 | Withdrawn |
| C0760099 | Length 45.00 cm | 36 | Withdrawn |
| C0761311 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0772410 | Length 75.00 cm | 36 | Withdrawn |
| B0266671 | Length 45.00 cm | 24 | Withdrawn |
| C0761494 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G0764892 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| B0266850 | Thread Material : silk | 24 | Withdrawn |
| C0766137 | Thread Material : silk | 36 | Withdrawn |
| G0765767 | Length 75.00 cm | 12 | Withdrawn |
| C0762547 | Length 45.00 cm | 36 | Withdrawn |
| C0266469 | Length 45.00 cm | 36 | Withdrawn |
| B0263672 | Size of Thread (USP – Others) : 0 | 24 | Withdrawn |
| C0284840 | Thread Material : silk | 36 | Withdrawn |
| C0764400 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0761273 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0766677 | Thread Material : silk | 36 | Withdrawn |
| C0761508 | Length 75.00 cm | 36 | Withdrawn |
| G0764191 | Thread Material : silk | 12 | Withdrawn |
| G0761311 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| G0760146 | Length 75.00 cm | 12 | Withdrawn |
| C0765554 | Length 75.00 cm | 36 | Withdrawn |
| B0760501 | Size of Thread (USP – Others) : 3/0 | 24 | Withdrawn |
| G0763421 | Thread Material : silk | 12 | Withdrawn |
| C0760951 | Length 75.00 cm | 36 | Withdrawn |
| C0767239 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0762760 | Thread Material : silk | 36 | Withdrawn |
| C0762636 | Length 75.00 cm | 36 | Withdrawn |
| G0762660 | Length 75.00 cm | 12 | Withdrawn |
| G0760316 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0764690 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G0763153 | Thread Material : silk | 12 | Withdrawn |
| C0764069 | Thread Material : silk | 36 | Withdrawn |
| C0760021 | Length 45.00 cm | 36 | Withdrawn |
| G0263850 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| C0761147 | Thread Material : silk | 36 | Withdrawn |
| C0765279 | Length 45.00 cm | 36 | Withdrawn |
| C0761998 | Length 90.00 cm | 36 | Withdrawn |
| B0263869 | Thread Material : silk | 24 | Withdrawn |
| G0760138 | Thread Material : silk | 12 | Withdrawn |
| C0766136 | Thread Material : silk | 36 | Withdrawn |
| C0764191 | Thread Material : silk | 36 | Withdrawn |
| C0770477 | Thread Material : silk | 36 | Withdrawn |
| G0769299 | Length 60.00 cm | 12 | Withdrawn |
| C0765023 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0762636 | Thread Material : silk | 12 | Withdrawn |
| C0761137 | Thread Material : silk | 36 | Withdrawn |
| C0766232 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0266825 | Thread Material : silk | 36 | Withdrawn |
| B0762210 | Length 45.00 cm | 24 | Withdrawn |
| C0766049 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0263869 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0765374 | Thread Material : silk | 36 | Withdrawn |
| B0762300 | Length 45.00 cm | 24 | Withdrawn |
| G0764582 | Thread Material : silk | 12 | Withdrawn |
| C0765378 | Thread Material : silk | 36 | Withdrawn |
| G0762970 | Length 75.00 cm | 12 | Withdrawn |
| C0770507 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| C0762440 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0761020 | Length 45.00 cm | 36 | Withdrawn |
| G0263672 | Length 60.00 cm | 12 | Withdrawn |
| G0263893 | Length 60.00 cm | 12 | Withdrawn |
| C0761478 | Thread Material : silk | 36 | Withdrawn |
| C0765212 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| G0762407 | Thread Material : silk | 12 | Withdrawn |
| B0266493 | Size of Thread (USP – Others) : 1 | 24 | Withdrawn |
| C0762393 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| G0772429 | Thread Material : silk | 12 | Withdrawn |
| C0770493 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0764230 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0766127 | Thread Material : silk | 36 | Withdrawn |
| C0765120 | Thread Material : silk | 36 | Withdrawn |
| C0766850 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0760120 | Thread Material : silk | 12 | Withdrawn |
| C0770442 | Thread Material : silk | 36 | Withdrawn |
| C0764086 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0760030 | Length 45.00 cm | 12 | Withdrawn |
| C0284874 | Thread Material : silk | 36 | Withdrawn |
| G0772410 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premicron | B Braun Surgical SA | 1,377 |
| Deknatel | Teleflex Medical LLC | 1,198 |
| FlexiGRAFT® | LifeNet Health | 992 |
| 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 |
| 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.