Filamide
Non-absorbable Polyamide Surgical Suture
3manufacturers in China registered for this device type
59catalogue 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 | Meril Endo Surgery PVT. Ltd., India |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K172149 |
| Record published | 2018-11-04 |
| Record revised | 2021-02-05 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store below 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| NYL501865 | 12 | In distribution | |
| NYL401667Z | 36 | In distribution | |
| NYL50661Z | 36 | In distribution | |
| NYL907717DN | 12 | In distribution | |
| NYL501666Z | 36 | In distribution | |
| NYL501661 | 12 | In distribution | |
| NYL20593Z | 36 | In distribution | |
| NYL50661 | 12 | In distribution | |
| NYL301663 | 12 | In distribution | |
| NYL601856 | 12 | In distribution | |
| NYL40699 | 12 | In distribution | |
| NYL601665 | 12 | In distribution | |
| NYL50698Z | 36 | In distribution | |
| NYL30627Z | 36 | In distribution | |
| NYL301669Z | 36 | In distribution | |
| NYL20664 | 12 | In distribution | |
| NYL701696 | 12 | In distribution | |
| NYL1009000DN | 12 | In distribution | |
| NYL1002830 | 12 | In distribution | |
| NYL201674Z | 36 | In distribution | |
| NYL20585Z | 36 | In distribution | |
| NYL1007707DN | 12 | In distribution | |
| NYL907760DN | 12 | In distribution | |
| NYL401662 | 12 | In distribution | |
| NYL501668Z | 36 | In distribution | |
| NYL40662 | 12 | In distribution | |
| NYL50749DN | 12 | In distribution | |
| NYL401864 | 12 | In distribution | |
| NYL301893 | 12 | In distribution | |
| NYL40662Z | 36 | In distribution | |
| NYL50913 | 12 | In distribution | |
| NYL902829 | 12 | In distribution | |
| NYL305669 | 12 | In distribution | |
| NYL30663Z | 36 | In distribution | |
| NYL900112 | 12 | In distribution | |
| NYL50698 | 12 | In distribution | |
| NYL301663Z | 36 | In distribution | |
| NYL50668 | 12 | In distribution | |
| NYL902809 | 12 | In distribution | |
| NYL601698 | 12 | In distribution | |
| NYL02490DNY | 24 | In distribution | |
| NYL401854 | 12 | In distribution | |
| NYL1009061 | 12 | In distribution | |
| NYL501668 | 12 | In distribution | |
| NYL601866 | 12 | In distribution | |
| NYL40699Z | 36 | In distribution | |
| NYL902890 | 12 | In distribution | |
| NYL60911 | 12 | In distribution | |
| NYL501895 | 12 | In distribution | |
| NYL902813 | 12 | In distribution | |
| NYL20664Z | 36 | In distribution | |
| NYL501955 | 12 | In distribution | |
| NYL501666 | 12 | In distribution | |
| NYL60697 | 12 | In distribution | |
| NYL401629Z | 36 | In distribution | |
| NYL802808 | 12 | In distribution | |
| NYL401667 | 12 | In distribution | |
| NYL1009060 | 12 | In distribution | |
| NYL301671Z | 36 | 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
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.