Sharpoint Plus
Nylon Black Pliable 5-0 1x18" PC-1
3manufacturers in China registered for this device type
73catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 | Surgical Specialties México, S. de R.L. de C.V. |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2019-06-16 |
| Record revised | 2021-02-05 (version 3) |
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 | Box of 12, box of 4, bag of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G535N | -1- USP | In distribution |
| A1856N | 6-0 USP | In distribution |
| A1955N | 5-0 USP | In distribution |
| G603N | -0- USP | In distribution |
| G602N | 2-0 USP | In distribution |
| G417N | 2-0 USP | In distribution |
| Y398N | -0- USP | In distribution |
| A691N | 4-0 USP | In distribution |
| G346N | -0- USP | In distribution |
| G334N | -0- USP | In distribution |
| G267N | -0- USP | In distribution |
| Y399N | -1- USP | In distribution |
| G977N | -1- USP | In distribution |
| G214N | 4-0 USP | In distribution |
| Y946N | -0- USP | In distribution |
| G344N | 3-0 USP | In distribution |
| M945N | 2-0 USP | In distribution |
| M493NB | 5-0 USP | In distribution |
| J8698S | 5-0 USP | In distribution |
| A1665N | 6-0 USP | In distribution |
| A1994N | 4-0 USP | In distribution |
| G376N | -0- USP | In distribution |
| Y266N | 2-0 USP | In distribution |
| G0392B | 4-0 USP | In distribution |
| Y416N | 3-0 USP | In distribution |
| Y215N | 3-0 USP | In distribution |
| G266N | 2-0 USP | In distribution |
| 917BB | 5-0 USP | In distribution |
| A699S | 4-0 USP | In distribution |
| Y945N | 2-0 USP | In distribution |
| G268N | -1- USP | In distribution |
| G947N | -1- USP | In distribution |
| A1691N | 3-0 USP | In distribution |
| A1667S | 4-0 USP | In distribution |
| A1674N | 2-0 USP | In distribution |
| G215N | 3-0 USP | In distribution |
| A585N | 2-0 USP | In distribution |
| A1673N | 3-0 USP | In distribution |
| A1894N | 4-0 USP | In distribution |
| A1697N | 2-0 USP | In distribution |
| Y496S | 4-0 USP | In distribution |
| A1683N | 3-0 USP | In distribution |
| A593N | 2-0 USP | In distribution |
| G261N | -1- USP | In distribution |
| G497S | 3-0 USP | In distribution |
| AG667N | 4-0 USP | In distribution |
| G869N | 2-0 USP | In distribution |
| G338N | 3-0 USP | In distribution |
| Y417N | 2-0 USP | In distribution |
| G270N | -0- USP | In distribution |
| M944N | 3-0 USP | In distribution |
| G946N | -0- USP | In distribution |
| Y494S | 4-0 USP | In distribution |
| Y214N | 4-0 USP | In distribution |
| A1893N | 3-0 USP | In distribution |
| D623B | 2-0 USP | In distribution |
| G944N | 3-0 USP | In distribution |
| Y316N | 3-0 USP | In distribution |
| A1855N | 5-0 USP | In distribution |
| G978N | -0- USP | In distribution |
| G347N | -1- USP | In distribution |
| Y415N | 4-0 USP | In distribution |
| G494S | 4-0 USP | In distribution |
| G957N | 2-0 USP | In distribution |
| J8682S | 4-0 USP | In distribution |
| G917N | 2-0 USP | In distribution |
| G259N | 2-0 USP | In distribution |
| G258N | 3-0 USP | In distribution |
| G345N | 2-0 USP | In distribution |
| G370N | -0- USP | In distribution |
| G415N | 4-0 USP | In distribution |
| G371N | -1- USP | In distribution |
| G958N | -0- USP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| WEGO-Nylon Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 279 |
| Ethilon | Ethicon, Inc. | 272 |
| Monosof | Covidien LP | 256 |
| DemeLON Multi | Demetech Corp. | 227 |
| Surgilon | Covidien LP | 135 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 127 |
| Supramid Extra | S. Jackson, Inc. | 119 |
| Mani Sutures Nylon | Mani, Inc. | 88 |
| Onatec | Surgical Specialties México, S. de R.L. de C.V. | 75 |
| Trelon | B Braun Surgical SA | 72 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
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 |
|---|---|---|---|
| N85060 | 1988-02-22 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. |
| N85316 | 1986-06-20 | ETHILON/NUROLON NYLON SUTURES | Ethicon, Inc. |
| N80838 | 1985-07-23 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. |
| N83511 | 1982-05-18 | NON-ABSORBABLE SUTURES NYLON | 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.