Mani Sutures Silk
75 catalogue numbers from 3851, listed by Mani, Inc., United States, under Suture, Nonabsorbable, Silk. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
75catalogue numbers in this listing
1510(k) clearance
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 | Mani, Inc., United States |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| Record published | 2016-06-04 |
| Record revised | 2023-10-02 (version 11) |
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, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3851 | Needle Length 13.0mm | In distribution |
| 26 | In distribution | |
| 3354S | Needle Length 10.0mm | In distribution |
| 37 | In distribution | |
| 34 | In distribution | |
| 3353 | Needle Length 13.0mm | In distribution |
| 3801S | Needle Length 13.0mm | In distribution |
| 3358S | Needle Length 13.0mm | In distribution |
| 1413 | Needle Length 6.0mm | In distribution |
| 3801 | Needle Length 13.0mm | In distribution |
| 3850S | Needle Length 14.0mm | In distribution |
| 4302S | Needle Length 14.0mm | In distribution |
| 2023 | Needle Length 6.5mm | In distribution |
| 3305 | Needle Length 11.0mm | In distribution |
| 3 | In distribution | |
| 1450 | Needle Length 6.0mm | In distribution |
| 4359S | Needle Length 13.0mm | In distribution |
| 11 | In distribution | |
| 2801 | Needle Length 6.5mm | In distribution |
| 2019 | Needle Length 7.0mm | In distribution |
| 2024 | Needle Length 6.5mm | In distribution |
| 22 | In distribution | |
| 1413S | Needle Length 6.0mm | In distribution |
| 2853 | Needle Length 7.0mm | In distribution |
| 1480 | Needle Length 6.0mm | In distribution |
| 14 | In distribution | |
| 2805 | Needle Length 8.0mm | In distribution |
| 24L | In distribution | |
| 5351 | Needle Length 16.0mm | In distribution |
| 27 | In distribution | |
| 2068S | Needle Length 8.0mm | In distribution |
| 2023S | Needle Length 6.5mm | In distribution |
| 3355 | Needle Length 13.0mm | In distribution |
| 2063 | Needle Length 6.5mm | In distribution |
| 29 | In distribution | |
| 17 | In distribution | |
| 2008 | Needle Length 6.5mm | In distribution |
| 3857 | Needle Length 25.0mm | In distribution |
| 3856S | Needle Length11.0mm | In distribution |
| 3356 | Needle Length 13.0mm | In distribution |
| 24 | In distribution | |
| 20 | In distribution | |
| 2 | In distribution | |
| 3355S | Needle Length 13.0mm | In distribution |
| 1453 | Needle Length 5.5mm | In distribution |
| 28 | In distribution | |
| 1 | In distribution | |
| 4351 | Needle Length 13.0mm | In distribution |
| 4351S | Needle Length 13.0mm | In distribution |
| 2020 | Needle Length 6.5mm | In distribution |
| 4350S | Needle Length 11.0mm | In distribution |
| 4359 | Needle Length 13.0mm | In distribution |
| 2051 | Needle Length 6.5mm | In distribution |
| 3855 | Needle Length 16.0mm | In distribution |
| 3305S | Needle Length 11.0mm | In distribution |
| 1467 | Needle Length 6.0mm | In distribution |
| 1466 | Needle Length 6.0mm | In distribution |
| 2024S | Needle Length 6.5mm | In distribution |
| 2008S | Needle Length 6.5mm | In distribution |
| 2804 | Needle Length 5.5mm | In distribution |
| 2020S | Needle Length 6.5mm | In distribution |
| 30 | In distribution | |
| 2062S | Needle Length 8.0mm | In distribution |
| 6 | In distribution | |
| 1419 | Needle Length 6.0mm | In distribution |
| 3861 | Needle Length 16.0mm | In distribution |
| 3855S | Needle Length 16.0mm | In distribution |
| 5 | In distribution | |
| 4360 | Needle Length 6.5mm | In distribution |
| 3366 | Needle Length 10.0mm | In distribution |
| 27L | In distribution | |
| 4300 | Needle Length 13.0mm | In distribution |
| 3856 | Needle Length 11.0mm | In distribution |
| 25 | In distribution | |
| 2860S | Needle Length 7.0mm | 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 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 100 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K053638 | 2006-05-19 |
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.