Sutralon
6-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 (140 degrees), length 8.00 mm, wire 0.28 mm / # of…
6-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 30 inch (76 cm) / Needle Specifications: ST-140-11, Spatula Tip, 3/8 (140 degrees), length 8.00 mm, wire 0.28 mm / # of needles: Double Arm
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 | Visionary Medical Supplies, Inc., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K994176 |
| Record published | 2016-05-13 |
| Record revised | 2021-02-05 (version 5) |
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 |
| Storage | Special storage condition: Keep away from chemicals and oxides |
| Packaging | Carton of 12, pouch |
| Sizes | Angle 140 to 160 °; outer diameter 0.15 to 0.28 mm; length 5.6 to 8 mm; length 15 to 76 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N640112 | Angle 140 ° | In distribution |
| N96062 | Angle 160 ° | In distribution |
| N106061 | Angle 160 ° | In distribution |
| N94081 | Length 40 cm | In distribution |
| N94061 | Length 15 cm | In distribution |
| N104082 | Angle 140 ° | In distribution |
| N84082 | Angle 140 ° | In distribution |
| N94062 | Angle 140 ° | In distribution |
| N104061 | Angle 140 ° | In distribution |
| N96061 | Length 30 cm | In distribution |
| N74092TP | Length 30 cm | In distribution |
| N104062 | Angle 140 ° | In distribution |
| N104081 | Length 40 cm | In distribution |
| N106062 | Angle 160 ° | In distribution |
| N94082 | Angle 140 ° | 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 |
|---|---|
| K994176 | 2000-02-08 |
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.