Microsuture
20 catalogue numbers from GEM170BK, listed by Riverpoint Medical LLC, United States, under Suture, Nonabsorbable, Synthetic, Polyamide. 3 manufacturers in China are registered for this product 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 | 2015-12-10 |
| Record revised | 2021-02-05 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GEM170BK | In distribution | |
| GEM171BK | In distribution | |
| GEM192BKC | In distribution | |
| GEM195BK | In distribution | |
| GEM177BK | In distribution | |
| GEM389BK | In distribution | |
| GEM116BK | In distribution | |
| GEM165BK | In distribution | |
| GEM395BK | In distribution | |
| GEM385BK | In distribution | |
| GEM188BK | In distribution | |
| GEM180BKC | In distribution | |
| GEM194BK | In distribution | |
| GEM192BK | In distribution | |
| GEM189BK | In distribution | |
| GEM382BK | In distribution | |
| GEM386BK | In distribution | |
| GEM395BKC | In distribution | |
| GEM180BK | In distribution | |
| GEM389BKC | 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.