Riverlon
61 catalogue numbers from 189BK, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
61catalogue numbers in this listing
1510(k) clearance
2recalls on this code
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 | Riverpoint Medical LLC, United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2020-07-10 |
| Record revised | 2021-02-05 (version 6) |
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, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 189BK | In distribution | |
| 180BK | In distribution | |
| 389BKC | In distribution | |
| 0116BK | In distribution | |
| 1663BK | In distribution | |
| 385BK | In distribution | |
| 395BKC | In distribution | |
| 171BK | In distribution | |
| 9000BK | In distribution | |
| 170BK | In distribution | |
| 176BK | In distribution | |
| 1919BK | In distribution | |
| 911BK | In distribution | |
| 661BK | In distribution | |
| 2510BK | In distribution | |
| 9013BK | In distribution | |
| 1667BK | In distribution | |
| 9003BK | In distribution | |
| 698BKC | In distribution | |
| 913BK | In distribution | |
| 1666BK | In distribution | |
| 389BK | In distribution | |
| 180BKC | In distribution | |
| 664BL | In distribution | |
| 395BK | In distribution | |
| 697BK | In distribution | |
| 192BKC | In distribution | |
| 945BK | In distribution | |
| 628BK | In distribution | |
| 188BK | In distribution | |
| 669BK | In distribution | |
| 1915BK | In distribution | |
| 1923BK | In distribution | |
| 7770BK | In distribution | |
| 192BK | In distribution | |
| 1273BK | In distribution | |
| 177BK | In distribution | |
| 147BK | In distribution | |
| 195BK | In distribution | |
| 944BK | In distribution | |
| 7756BK | In distribution | |
| 662BL | In distribution | |
| 668BK | In distribution | |
| 663BL | In distribution | |
| 662BK | In distribution | |
| 1669BK | In distribution | |
| 116BK | In distribution | |
| 660BK | In distribution | |
| 386BK | In distribution | |
| 928BK | In distribution | |
| 1696BK | In distribution | |
| 2534BK | In distribution | |
| 664BK | In distribution | |
| 698BK | In distribution | |
| 663BK | In distribution | |
| 165BK | In distribution | |
| 2808BK | In distribution | |
| 1698BK | In distribution | |
| 931BK | In distribution | |
| 194BK | In distribution | |
| 699BK | 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 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 73 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152795 | 2015-10-28 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-08-05 | Class II | Nonconforming Material/Component | Polypropylene Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. | 61 boxes distributed in the US only | 2016-12-22 |
| 2016-08-05 | Class II | Nonconforming Material/Component | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. | 2110 boxes distributed in the US and 72 boxes distributed ou | 2016-12-22 |
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.