Unify Nylon Surgical Sutures
UNIFY Nylon Ultra-Premium Microsutures , Size10-0, 6.4mm 3/8 Circle Spatula Double Micro-Needle, 12". Black.
3manufacturers in China registered for this device type
32catalogue 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 | Applied Dental, Inc. |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| 510(k) | K080684 |
| Record published | 2017-07-25 |
| Record revised | 2026-04-22 (version 7) |
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 | Box of 12, case of 100, box of 36, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-N410R13-B | In distribution | |
| XXS-N1012S6D | In distribution | |
| M-N418R19 | In distribution | |
| S-N718SP13 | In distribution | |
| M-N410R19-B | In distribution | |
| XXL-2N30T40 | In distribution | |
| XXS-N1007S6 | In distribution | |
| M-N418XR19 | In distribution | |
| S-N610R13-B | In distribution | |
| S-N418R13 | In distribution | |
| XS-N618R11 | In distribution | |
| S-N618R13 | In distribution | |
| M-N330R19 | In distribution | |
| XL-N230T36 | In distribution | |
| XL-N030T36 | In distribution | |
| S-N510R13-B | In distribution | |
| S-N618XR13 | In distribution | |
| M-N518R16 | In distribution | |
| S-N418XR13 | In distribution | |
| M-N518R19 | In distribution | |
| M-N418R16 | In distribution | |
| S-N518R13 | In distribution | |
| M-N518XR19 | In distribution | |
| XXS-N905T5 | In distribution | |
| M-N510R19-B | In distribution | |
| M-N410XR19-B | In distribution | |
| XXL-N230K60 | In distribution | |
| XL-N030R30 | In distribution | |
| S-N518XR13 | In distribution | |
| XXS-N807T6 | In distribution | |
| XXS-N1005T4 | In distribution | |
| M-N430R19 | 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.