Rtmed
34 catalogue numbers from 4/0 75cm Round Bodied 1/2 16mm, listed by Shandong Haidike Medical Products Co., Ltd., China, under Suture, Nonabsorbable, Silk. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
34catalogue 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 | Shandong Haidike Medical Products Co., Ltd., China |
|---|---|
| FDA product code | GAP |
| Device type | Suture, Nonabsorbable, Silk |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5030 |
| Establishment | Manufacturer |
| 510(k) | K232355 |
| Record published | 2024-02-22 |
| Record revised | 2024-04-12 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4/0 75cm Round Bodied 1/2 16mm | In distribution | |
| 6/0 Without Needle 150cm | In distribution | |
| 2/0 75cm Cutting 3/8 30mm | In distribution | |
| 1 Without Needle 150cm | In distribution | |
| 3/0 75cm Reverse Cutting 3/8 26mm | In distribution | |
| 3/0 75cm Reverse Cutting 3/8 19mm | In distribution | |
| 3/0 75cm Round Bodied 1/2 30mm | In distribution | |
| 5/0 Without Needle 150cm | In distribution | |
| 1 75cm Cutting 3/8 40mm | In distribution | |
| 2/0 75cm Round Bodied 1/2 35mm | In distribution | |
| 6-0 45cm Cutting 3/8 9mm | In distribution | |
| 4/0 75cm Reverse Cutting 3/8 19mm | In distribution | |
| 3/0 75cm Cutting 3/8 24mm | In distribution | |
| 1 75cm Reverse Cutting 3/8 37mm | In distribution | |
| 2/0 75cm Round Bodied 1/2 24mm | In distribution | |
| 2 75cm Cutting 3/8 40mm | In distribution | |
| 4/0 Without Needle 150cm | In distribution | |
| 3/0 75cm Cutting 3/8 30mm | In distribution | |
| 6/0 45cm Round Bodied 1/2 10mm | In distribution | |
| 2/0 75cm Reverse Cutting 3/8 26mm | In distribution | |
| 2 75cm Round Bodied 1/2 37mm | In distribution | |
| 1 75cm Round Bodied 1/2 37mm | In distribution | |
| 0 75cm Reverse Cutting 3/8 37mm | In distribution | |
| 0 75cm Cutting 3/8 40mm | In distribution | |
| 5/0 75cm Round Bodied 1/2 13mm | In distribution | |
| 0 75cm Round Bodied 1/2 37mm | In distribution | |
| 4/0 75cm Cutting 3/8 16mm | In distribution | |
| 3/0 Without Needle 150cm | In distribution | |
| 2/0 Without Needle 150cm | In distribution | |
| 2 Without Needle 150cm | In distribution | |
| 2 75cm Cutting 3/8 45mm | In distribution | |
| 5/0 75cm Cutting 3/8 16mm | In distribution | |
| 0 Without Needle 150cm | In distribution | |
| 2 75cm Round Bodied 1/2 40mm | 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 |
| 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 |
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.