Atramat
Atramat Silk Surgical Suture Black USP 4-0 EP 1,5, 45 CM Double Needle P-PE-13 Supra-Sharp Reverse Cutting 13 MM 3/8 Circle Seda Negra USP 4-0, 45 CM Doble Aguja P-PE-13 Reverso Cortante…
Atramat Silk Surgical Suture Black USP 4-0 EP 1,5, 45 CM Double Needle P-PE-13 Supra-Sharp Reverse Cutting 13 MM 3/8 Circle Seda Negra USP 4-0, 45 CM Doble Aguja P-PE-13 Reverso Cortante Supra-Sharp 13 MM 3/8 Circulo
4manufacturers in China registered for this device type
100catalogue 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 | Internacional Farmacéutica S.A DE C.V, Mexico |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| 510(k) | K905287 |
| Record published | 2018-07-04 |
| Record revised | 2021-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 65 % RH |
| Packaging | Dozen of 12, dozne of 12 |
| Sizes | Length 6 to 75 mm; length 45 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEDA | Length 37 mm | In distribution |
| SEDA | Length 11 mm | In distribution |
| SEDA | Length 19 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SEDA | Length 60 mm | In distribution |
| SILK | Length 26 mm | In distribution |
| SILK | Length 13 mm | In distribution |
| SEDA | Length 37 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 13 mm | In distribution |
| SEDA | Length 24 mm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 37 mm | In distribution |
| SEDA | 3/8 CIRCLE | In distribution |
| SEDA | Length 30 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 24 mm | In distribution |
| SILK | Length 6 mm | In distribution |
| SEDA | Length 19 mm | In distribution |
| SEDA | Length 60 mm | In distribution |
| SILK | Length 19 mm | In distribution |
| SILK | Length 30 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SEDA | Length 20 mm | In distribution |
| SEDA | Length 45 cm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SILK | Length 24 mm | In distribution |
| SEDA | 75 CM | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SILK | Length 19 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SEDA | Length 12 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 24 mm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 6.6 mm | In distribution |
| SEDA | Length 30 mm | In distribution |
| SILK | Length 19 mm | In distribution |
| SEDA | Length 20 mm | In distribution |
| SEDA | Length 19 mm | In distribution |
| SILK | Length 12 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 22 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 24 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SEDA | Length 75 mm | In distribution |
| SEDA | Length 12 mm | In distribution |
| SEDA | Length 24 mm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SEDA | Length 16 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SILK | Length 19 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 19 mm | In distribution |
| SILK | Length 37 mm | In distribution |
| SILK | USP 3-0 EP 2 | In distribution |
| SEDA | Length 16 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SEDA | Length 36 mm | In distribution |
| SEDA | Length 8 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 26 mm | In distribution |
| SILK | Length 60 mm | In distribution |
| SEDA | ATRAMAT SILK | In distribution |
| SEDA | Length 37 mm | In distribution |
| SEDA | Length 45 cm | In distribution |
| SILK | USP 1 EP 4 | In distribution |
| SEDA | Length 60 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 6 mm | In distribution |
| SEDA | Length 24 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SILK | Length 19 mm | In distribution |
| SEDA | Length 6.6 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SILK | USP 4-0 EP 1,5 | In distribution |
| SEDA | 3/8 CIRCLE | In distribution |
| SILK | Length 24 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SILK | Length 26 mm | In distribution |
| SILK | Length 26 mm | In distribution |
| SEDA | Length 19 mm | In distribution |
| SILK | Length 37 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SILK | Length 26 mm | In distribution |
| SEDA | Length 26 mm | In distribution |
| SEDA | Length 8 mm | In distribution |
| SEDA | Length 17 mm | In distribution |
| SILK | Length 60 mm | In distribution |
| SEDA | WITHOUT NEEDLE | In distribution |
| SEDA | Length 19 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeSILK | Demetech Corp. | 1,198 |
| Silkam | B Braun Surgical SA | 632 |
| 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 |
| 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.