Silkam
Silkam Black 6/0 (0.7) 45CM 2XDSMP11 (M)
4manufacturers in China registered for this device type
632catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | 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 | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| Record published | 2015-08-05 |
| Record revised | 2026-03-27 (version 14) |
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 60, carton of 30 |
| Sizes | Length 30 to 250 cm |
| Distribution end date | 2025-11-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B0284874 | Length 60.00 cm | 24 | Withdrawn |
| G0760471 | Thread Material : silk | 12 | Withdrawn |
| C0768818 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0760560 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| X0768723 | Length 45.0 cm | 4 | Withdrawn |
| C0266477 | Length 45.00 cm | 36 | Withdrawn |
| C0762229 | Thread Material : silk | 36 | Withdrawn |
| G0762954 | Length 75.00 cm | 12 | Withdrawn |
| C0763223 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0764581 | Thread Material : silk | 36 | Withdrawn |
| C0262129 | Length 150.00 cm | 36 | Withdrawn |
| G0762229 | Thread Material : silk | 12 | Withdrawn |
| C0761192 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X0762466 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C0766700 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0765210 | Thread Material : silk | 36 | Withdrawn |
| C0761079 | Thread Material : silk | 36 | Withdrawn |
| C0762377 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0736023 | Thread Material : silk | 36 | Withdrawn |
| G0762024 | Length 45.00 cm | 12 | Withdrawn |
| G0765082 | Length 75.00 cm | 12 | Withdrawn |
| G0262110 | Length 150.00 cm | 12 | Withdrawn |
| X0266671 | Length 45.0 cm | 4 | Withdrawn |
| C0766135 | Thread Material : silk | 36 | Withdrawn |
| G0761060 | Length 45.00 cm | 12 | Withdrawn |
| X0262102 | Thread Material : silk | 4 | Withdrawn |
| C0268658 | Thread Material : silk | 36 | Withdrawn |
| C0760447 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0761133 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0264458 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X0264067 | Thread Material : silk | 4 | Withdrawn |
| C0762644 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0764590 | Length 75.00 cm | 36 | Withdrawn |
| C0762598 | Thread Material : silk | 36 | Withdrawn |
| C0764396 | Thread Material : silk | 36 | Withdrawn |
| C0765163 | Thread Material : silk | 36 | Withdrawn |
| C0766950 | Thread Material : silk | 36 | Withdrawn |
| G0264644 | Length 75.00 cm | 12 | Withdrawn |
| G0266698 | Thread Material : silk | 12 | Withdrawn |
| C0766186 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0760986 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| C0762474 | Thread Material : silk | 36 | Withdrawn |
| C0762342 | Length 75.00 cm | 36 | Withdrawn |
| C0760420 | Thread Material : silk | 36 | Withdrawn |
| C0760315 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0762091 | Length 45.00 cm | 36 | Withdrawn |
| G0762598 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0760153 | Thread Material : silk | 36 | Withdrawn |
| C0764698 | Length 75.00 cm | 36 | Withdrawn |
| X0766224 | Thread Material : silk | 4 | Withdrawn |
| X0765309 | Thread Material : silk | 4 | Withdrawn |
| C0760293 | Length 75.00 cm | 36 | Withdrawn |
| C0766682 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X0766038 | Thread Material : silk | 4 | Withdrawn |
| X0761133 | Length 45.00 cm | 4 | Withdrawn |
| C0765238 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| G0262072 | Thread Material : silk | 12 | Withdrawn |
| G0766208 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| C0762970 | Length 75.00 cm | 36 | Withdrawn |
| G0262099 | Length 150.00 cm | 12 | Withdrawn |
| C0765392 | Length 90.0 cm | 36 | Withdrawn |
| C0763144 | Thread Material : silk | 36 | Withdrawn |
| C0765171 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| X0761010 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| C0760413 | Length 75.00 cm | 36 | Withdrawn |
| C0765317 | Thread Material : silk | 36 | Withdrawn |
| C0765082 | Length 75.00 cm | 36 | Withdrawn |
| X0262137 | Size of Thread (USP – Others) : 5 | 4 | Withdrawn |
| X0762083 | Thread Material : silk | 4 | Withdrawn |
| X0266469 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| X0266477 | Length 45.0 cm | 4 | Withdrawn |
| C0766275 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0266248 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0762776 | Size of Thread (USP – Others) : 1 | 36 | Withdrawn |
| C0762210 | Thread Material : silk | 36 | Withdrawn |
| M0766076 | Size of Thread (USP – Others) : 4/0 | 6 | Withdrawn |
| G0764647 | Size of Thread (USP – Others) : 1 | 12 | Withdrawn |
| C0766169 | Thread Material : silk | 36 | Withdrawn |
| C0765791 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0766138 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0768065 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| C0769215 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G0760137 | Length 75.00 cm | 12 | Withdrawn |
| X0764698 | Size of Thread (USP – Others) : 2 | 4 | Withdrawn |
| X0264091 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C0769231 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| G0762415 | Thread Material : silk | 12 | Withdrawn |
| X0765554 | Size of Thread (USP – Others) : 2/0 | 4 | Withdrawn |
| X0762431 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| X0765082 | Thread Material : silk | 4 | Withdrawn |
| C0764159 | Thread Material : silk | 36 | Withdrawn |
| C0762679 | Length 75.00 cm | 36 | Withdrawn |
| C0262064 | Thread Material : silk | 36 | Withdrawn |
| C0766498 | Thread Material : silk | 36 | Withdrawn |
| X0265152 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C0761060 | Thread Material : silk | 36 | Withdrawn |
| X0762547 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| G0760480 | Length 75.00 cm | 12 | Withdrawn |
| C0760927 | Length 75.00 cm | 36 | Withdrawn |
| X0765511 | Thread Material : silk | 4 | Withdrawn |
| G0762326 | Length 45.00 cm | 12 | Withdrawn |
| G0262056 | Thread Material : silk | 12 | Withdrawn |
| C0263664 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0762199 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C0764825 | Thread Material : silk | 36 | Withdrawn |
| G0762059 | Length 45.00 cm | 12 | Withdrawn |
| X0765228 | Thread Material : silk | 4 | Withdrawn |
| G0764140 | Size of Thread (USP – Others) : 3/0 | 12 | Withdrawn |
| X0766046 | Length 45.0 cm | 4 | Withdrawn |
| C0262056 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| X0762415 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| C0763527 | Length 75.00 cm | 36 | Withdrawn |
| C0764957 | Thread Material : silk | 36 | Withdrawn |
| C0764303 | Length 75.00 cm | 36 | Withdrawn |
| X0768464 | Size of Thread (USP – Others) : 6/0 | 4 | Withdrawn |
| M0766115 | Size of Thread (USP – Others) : 4/0 | 6 | Withdrawn |
| X0266450 | Thread Material : silk | 4 | Withdrawn |
| C0762130 | Thread Material : silk | 36 | Withdrawn |
| G0264490 | Thread Material : silk | 12 | Withdrawn |
| C0765325 | Thread Material : silk | 36 | Withdrawn |
| C0760137 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X0762059 | Size of Thread (USP – Others) : 3/0 | 4 | Withdrawn |
| X0260487 | Size of Thread (USP – Others) : 5 | 4 | Withdrawn |
| C0768464 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G0264652 | Length 75.00 cm | 12 | Withdrawn |
| X0262056 | Thread Material : silk | 4 | Withdrawn |
| C0762601 | Size of Thread (USP – Others) : 0 | 36 | Withdrawn |
| C0761206 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X0762423 | Length 75.0 cm | 4 | Withdrawn |
| X0266256 | Length 45.0 cm | 4 | Withdrawn |
| G0262102 | Thread Material : silk | 12 | Withdrawn |
| G0762130 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| X0760293 | Length 75.0 cm | 4 | Withdrawn |
| B0262137 | Length 150.00 cm | 24 | Withdrawn |
| C0762741 | Length 75.00 cm | 36 | Withdrawn |
| X0762504 | Thread Material : silk | 4 | Withdrawn |
| C0266647 | Thread Material : silk | 36 | Withdrawn |
| X0762229 | Length 45.00 cm | 4 | Withdrawn |
| X0762610 | Length 75.0 cm | 4 | Withdrawn |
| G0765201 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| X0762598 | Length 75.00 cm | 4 | Withdrawn |
| G0760145 | Thread Material : silk | 12 | Withdrawn |
| G0762342 | Size of Thread (USP – Others) : 4/0 | 12 | Withdrawn |
| G0260452 | Length 250.00 cm | 12 | Withdrawn |
| C0768472 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| X0760153 | Length 75.0 cm | 4 | Withdrawn |
| C0766704 | Thread Material : silk | 36 | Withdrawn |
| G0762202 | Length 45.00 cm | 12 | Withdrawn |
| X0260428 | Thread Material : silk | 4 | Withdrawn |
| G0760528 | Size of Thread (USP – Others) : 0 | 12 | Withdrawn |
| C0762709 | Thread Material : silk | 36 | Withdrawn |
| C0762016 | Length 75.00 cm | 36 | Withdrawn |
| C0766216 | Size of Thread (USP – Others) : 6/0 | 36 | Withdrawn |
| G0766038 | Size of Thread (USP – Others) : 7/0 | 12 | Withdrawn |
| C0762415 | Thread Material : silk | 36 | Withdrawn |
| C0766208 | Thread Material : silk | 36 | Withdrawn |
| C0268640 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| X0260444 | Length 250.00 cm | 4 | Withdrawn |
| X0762300 | Length 45.0 cm | 4 | Withdrawn |
| X0762148 | Thread Material : silk | 4 | Withdrawn |
| G0765198 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| C0761028 | Thread Material : silk | 36 | Withdrawn |
| C0765597 | Length 75.00 cm | 36 | Withdrawn |
| C0760528 | Length 75.00 cm | 36 | Withdrawn |
| X0762377 | Length 75.0 cm | 4 | Withdrawn |
| G0762466 | Thread Material : silk | 12 | Withdrawn |
| G0762369 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0760242 | Thread Material : silk | 36 | Withdrawn |
| C0767158 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| G0762563 | Thread Material : silk | 12 | Withdrawn |
| G0768022 | Thread Material : silk | 12 | Withdrawn |
| C0765104 | Length 45.00 cm | 36 | Withdrawn |
| C0762121 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C0764065 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| C0264075 | Length 75.00 cm | 36 | Withdrawn |
| X0760480 | Length 75.00 cm | 4 | Withdrawn |
| B0262110 | Size of Thread (USP – Others) : 3 | 24 | Withdrawn |
| C0761298 | Thread Material : silk | 36 | Withdrawn |
| C0766201 | Size of Thread (USP – Others) : 2/0 | 36 | Withdrawn |
| X0762768 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| C0764655 | Length 75.00 cm | 36 | Withdrawn |
| C0264466 | Thread Material : silk | 36 | Withdrawn |
| G0762490 | Thread Material : silk | 12 | Withdrawn |
| X0760510 | Thread Material : silk | 4 | Withdrawn |
| C0764892 | Length 75.00 cm | 36 | Withdrawn |
| C0265373 | Length 60.00 cm | 36 | Withdrawn |
| X0262064 | Length 150.00 cm | 4 | Withdrawn |
| G0262064 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0762245 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| C0765309 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0266671 | Thread Material : silk | 12 | Withdrawn |
| X0760528 | Length 75.0 cm | 4 | Withdrawn |
| C0766038 | Size of Thread (USP – Others) : 7/0 | 36 | Withdrawn |
| C0232068 | Length 150.00 cm | 36 | Withdrawn |
| C0764760 | Length 100.00 cm | 36 | Withdrawn |
| X0760439 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| C0264474 | Thread Material : silk | 36 | Withdrawn |
| X0768065 | Length 45.0 cm | 4 | Withdrawn |
| C0762032 | Length 45.00 cm | 36 | Withdrawn |
| C0266450 | Thread Material : silk | 36 | Withdrawn |
| C0762059 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0765473 | Length 45.00 cm | 36 | Withdrawn |
| C0765295 | Thread Material : silk | 36 | Withdrawn |
| C0769193 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| B0264113 | Thread Material : silk | 24 | Withdrawn |
| C0765767 | Size of Thread (USP – Others) : 4/0 | 36 | Withdrawn |
| C0769100 | Thread Material : silk | 36 | Withdrawn |
| C0762660 | Thread Material : silk | 36 | Withdrawn |
| C0765782 | Length 90.0 cm | 36 | Withdrawn |
| C0772429 | Thread Material : silk | 36 | Withdrawn |
| C0766283 | Thread Material : silk | 36 | Withdrawn |
| G0760420 | Size of Thread (USP – Others) : 2/0 | 12 | Withdrawn |
| C0764302 | Thread Material : silk | 36 | Withdrawn |
| X0768278 | Thread Material : silk | 4 | Withdrawn |
| C0266299 | Thread Material : silk | 36 | Withdrawn |
| G0260410 | Thread Material : silk | 12 | Withdrawn |
| C0264652 | Thread Material : silk | 36 | Withdrawn |
| C0769299 | Thread Material : silk | 36 | Withdrawn |
| G0264067 | Thread Material : silk | 12 | Withdrawn |
| X0762369 | Length 75.0 cm | 4 | Withdrawn |
| C0764000 | Thread Material : silk | 36 | Withdrawn |
| C0266302 | Size of Thread (USP – Others) : 2 | 36 | Withdrawn |
| C0760536 | Thread Material : silk | 36 | Withdrawn |
| X0762679 | Size of Thread (USP – Others) : 0 | 4 | Withdrawn |
| G0762091 | Length 45.00 cm | 12 | Withdrawn |
| B0767026 | Thread Material : silk | 24 | Withdrawn |
| C0760412 | Size of Thread (USP – Others) : 3/0 | 36 | Withdrawn |
| C0760625 | Thread Material : silk | 36 | Withdrawn |
| G0762423 | Length 75.00 cm | 12 | Withdrawn |
| G0762075 | Size of Thread (USP – Others) : 5/0 | 12 | Withdrawn |
| X0766186 | Length 45.00 cm | 4 | Withdrawn |
| X0766135 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
| G0760280 | Size of Thread (USP – Others) : 2 | 12 | Withdrawn |
| G0762431 | Length 75.00 cm | 12 | Withdrawn |
| X0760080 | Thread Material : silk | 4 | Withdrawn |
| X0760927 | Size of Thread (USP – Others) : 1 | 4 | Withdrawn |
| X0762121 | Thread Material : silk | 4 | Withdrawn |
| C0262072 | Thread Material : silk | 36 | Withdrawn |
| G0765805 | Length 90.00 cm | 12 | Withdrawn |
| G0262129 | Thread Material : silk | 12 | Withdrawn |
| X0262145 | Thread Material : silk | 4 | Withdrawn |
| G0260487 | Length 250.00 cm | 12 | Withdrawn |
| C0767023 | Length 45.00 cm | 36 | Withdrawn |
| C0765490 | Size of Thread (USP – Others) : 5/0 | 36 | Withdrawn |
| G0762709 | Thread Material : silk | 12 | Withdrawn |
| X0762024 | Length 45.00 cm | 4 | Withdrawn |
| C0764248 | Thread Material : silk | 36 | Withdrawn |
| C0264660 | Thread Material : silk | 36 | Withdrawn |
| C0266655 | Length 45.00 cm | 36 | Withdrawn |
| X0262048 | Size of Thread (USP – Others) : 4/0 | 4 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeSILK | Demetech Corp. | 1,198 |
| Wego-Silk Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 404 |
| Sofsilk | Covidien LP | 319 |
| Perma-Hand | Ethicon, Inc. | 231 |
| Deknatel | Teleflex Medical LLC | 109 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 100 |
| Mani Sutures Silk | Mani, Inc. | 75 |
| Suture, Nonabsorbable, Silk | C P Medical Inc. | 48 |
| Sutumed | Unilene S.A.C. | 44 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 36 |
| Silk | Resorba Medical GmbH | 35 |
| Rtmed | Shandong Haidike Medical Products Co., Ltd. | 34 |
Showing 12 of 205. All products under Suture, Nonabsorbable, Silk
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 |
|---|---|---|---|
| N80989 | 1989-08-01 | SILK SUTURES | Lukens Corp. |
| N84348 | 1989-06-16 | NONABSORBABLE SURG. SUTURES, BRAIDED SILK | Deknatel, Inc. |
| N85143 | 1987-04-03 | SUTURES | Sharpoint, Inc. |
| N11397 | 1982-12-08 | SILK SUTURE, NONABSORBABLE SURG. SUTURE, USP | Ethicon, Inc. |
| N84047 | 1982-07-16 | SILK NONABSORBABLE SUTURES, USP | 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.