DemeLON
Nylon Monofilament, Sterile, Nonabsorbable Surgical Suture
3manufacturers in China registered for this device type
1,800catalogue numbers in this listing
1510(k) clearance
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 | Demetech Corp., United States |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K023028 |
| Record published | 2019-06-18 |
| Record revised | 2024-03-22 (version 8) |
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 |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Pack of 12, pack of 305824104 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NL86800,65G7P | In distribution | |
| NL263026B6P | In distribution | |
| NL1090190F2P | In distribution | |
| NL163021F4P | In distribution | |
| NL6x1930 | In distribution | |
| NL192055A4P | In distribution | |
| NL262039F4P | In distribution | |
| NL265013B0P | In distribution | |
| NL294039F4P | In distribution | |
| NL163075Ax22P | In distribution | |
| NL265026F11M | In distribution | |
| NL560140B0P | In distribution | |
| NL160026B16P | In distribution | |
| NL163026F13M | In distribution | |
| NL260135F2P | In distribution | |
| NL761100,5F0P | In distribution | |
| NL263030F0P | In distribution | |
| NL266017B0P | In distribution | |
| NL1160040B4P | In distribution | |
| NL1060030F4P | In distribution | |
| NL293017F0P | In distribution | |
| NL361045F4P | In distribution | |
| NL292035B4P | In distribution | |
| NL165017B0P | In distribution | |
| NL360190F2P | In distribution | |
| NL262035B4P | In distribution | |
| NL864012F4P | In distribution | |
| NL1190237B0P | In distribution | |
| NL1160048B4P | In distribution | |
| NL174017B13M | In distribution | |
| NL293026B0P | In distribution | |
| NL165011F2P | In distribution | |
| NL560150BI0P | In distribution | |
| NL265026F0P | In distribution | |
| NL165019F12P | In distribution | |
| NL79900,5F0P | In distribution | |
| NM12x1630 | In distribution | |
| NL12x1730 | In distribution | |
| NL590225BI0P | In distribution | |
| NL290024F4P | In distribution | |
| NL1163020F4P | In distribution | |
| NL165015F2P | In distribution | |
| NL166012F0P | In distribution | |
| NL861000,6B7P | In distribution | |
| NL166012F13M | In distribution | |
| NL364045F4P | In distribution | |
| NL266019F4P | In distribution | |
| NL261030F2P | In distribution | |
| NL260130F2P | In distribution | |
| NL260138F4P | In distribution | |
| NL1060145F4P | In distribution | |
| NL260035F2P | In distribution | |
| NL260175F4P | In distribution | |
| NL1560140B16P | In distribution | |
| NL260275G4P | In distribution | |
| NL260050B0P | In distribution | |
| NL260145B4P | In distribution | |
| NL165016F13M | In distribution | |
| NL165022B4P | In distribution | |
| NL195011F13M | In distribution | |
| NL263030A4P | In distribution | |
| NL262060A4P | In distribution | |
| NL264015B4P | In distribution | |
| NL194020F2P | In distribution | |
| NL1092060A4P | In distribution | |
| NL861000,65G10P | In distribution | |
| NL1065020F2P | In distribution | |
| NL390130B0P | In distribution | |
| NL195013B0P | In distribution | |
| NL1063050F2P | In distribution | |
| NL3165016F13M | In distribution | |
| NL263060A4P | In distribution | |
| NL162036B4P | In distribution | |
| NL263040F4P | In distribution | |
| NL162030B0P | In distribution | |
| NL192026F13M | In distribution | |
| NL1062030B4P | In distribution | |
| NL292025F13M | In distribution | |
| NL175013F13M | In distribution | |
| NL1060160B4P | In distribution | |
| NL293017F4P | In distribution | |
| NL264026B2P | In distribution | |
| NL994019F4P | In distribution | |
| NL260024F13M | In distribution | |
| NL263017B0P | In distribution | |
| NL162024F13M | In distribution | |
| NL2940 | In distribution | |
| NL76900,4F0P | In distribution | |
| NL260130F4P | In distribution | |
| NL164015F4P | In distribution | |
| NL163020F4P | In distribution | |
| NL192040F4P | In distribution | |
| NL166015F17P | In distribution | |
| NL163025F0P | In distribution | |
| NL86800,65F7P | In distribution | |
| NL360141B0P | In distribution | |
| NL560040BI1P | In distribution | |
| NL260136B0P | In distribution | |
| NL2961000,6C7P | In distribution | |
| NL364020B4P | In distribution | |
| NL1166013F13M | In distribution | |
| NL260037B4P | In distribution | |
| NL163020B0P | In distribution | |
| NL293019F13M | In distribution | |
| NL294022B4P | In distribution | |
| NL194013F4P | In distribution | |
| NL194019F13M | In distribution | |
| NL193026F12P | In distribution | |
| NL360027B0P | In distribution | |
| NL162025F0P | In distribution | |
| NL2961000,6B9P | In distribution | |
| NL2461000,6G7P | In distribution | |
| NL1063030B4P | In distribution | |
| NL1094020F4P | In distribution | |
| NL290130F4P | In distribution | |
| NL1063036B4P | In distribution | |
| NL292036B26P | In distribution | |
| NL260190F4P | In distribution | |
| NL195026F17P | In distribution | |
| NL260140F2P | In distribution | |
| NL260245A2P | In distribution | |
| NL293037F4P | In distribution | |
| NL165016F4P | In distribution | |
| NL165012B0P | In distribution | |
| NL362045B4P | In distribution | |
| NL106900,5G0P | In distribution | |
| NL1162045F4P | In distribution | |
| NL16300,65G7P | In distribution | |
| NL265024F2P | In distribution | |
| NL1063025F0P | In distribution | |
| NL665016F4P | In distribution | |
| NL293035B4P | In distribution | |
| NL363045F2P | In distribution | |
| NL590040B0P | In distribution | |
| NL86900,6F0P | In distribution | |
| NL1063020F2P | In distribution | |
| NL164013F12P | In distribution | |
| NL16800,8G0P | In distribution | |
| NL164024F4R | In distribution | |
| NL76800,5F0P | In distribution | |
| NL263020F4P | In distribution | |
| NL560265B0P | In distribution | |
| NL292026F12P | In distribution | |
| NL290277G4P | In distribution | |
| NL261000,65G7P | In distribution | |
| NL264030F2P | In distribution | |
| NL260024B4P | In distribution | |
| NL295015B2P | In distribution | |
| NL262025F13M | In distribution | |
| NL160040F4P | In distribution | |
| NL861000,5C9P | In distribution | |
| NL266010B0P | In distribution | |
| NL265011F4P | In distribution | |
| NL2161000,65F7P | In distribution | |
| NL560048B0P | In distribution | |
| NL163026F4P | In distribution | |
| NL861000,6C9P | In distribution | |
| NL2x3920 | In distribution | |
| NL267013F0P | In distribution | |
| NL263020F0P | In distribution | |
| NL262024A4P | In distribution | |
| NL195025F19P | In distribution | |
| NL262027F4P | In distribution | |
| NL262035F2P | In distribution | |
| NL163022B0P | In distribution | |
| NL167013F13M | In distribution | |
| NL166016F2P | In distribution | |
| NL264015F4P | In distribution | |
| NL263017F4P | In distribution | |
| NL165013F2P | In distribution | |
| NL263035B4P | In distribution | |
| NL260140BI0P | In distribution | |
| NL1166010G13M | In distribution | |
| NL264016F17P | In distribution | |
| NL296019F4P | In distribution | |
| NL171000,65G7P | In distribution | |
| NL1093024F4P | In distribution | |
| NL162024F2P | In distribution | |
| NL262027B6P | In distribution | |
| NL263024F4P | In distribution | |
| NL590050BI0P | In distribution | |
| NL861000,65G9P | In distribution | |
| NL293040F2P | In distribution | |
| NL163026F19P | In distribution | |
| NL161000,65F9P | In distribution | |
| NL290030B0P | In distribution | |
| NL16800,8F0P | In distribution | |
| NL164026B4P | In distribution | |
| NL163040F4P | In distribution | |
| NL167011F2P | In distribution | |
| NL292065AX20P | In distribution | |
| NL1163020B0P | In distribution | |
| NL263026F6P | In distribution | |
| NL560148B16P | In distribution | |
| NL265017F2P | In distribution | |
| NL1060240F4P | In distribution | |
| NL264020B4P | In distribution | |
| NL1064016F11M | In distribution | |
| NL16800,65F0P | In distribution | |
| NL260075F4P | In distribution | |
| NL86900,65G10P | In distribution | |
| NL196013B0P | In distribution | |
| NL164022B4P | In distribution | |
| NL185013F13M | In distribution | |
| NL76800,6B0P | In distribution | |
| NL362045F4P | In distribution | |
| NL1166019F4P | In distribution | |
| NL165020B0P | In distribution | |
| NL1162035B0P | In distribution | |
| NL865012F4P | In distribution | |
| NL993017B0P | In distribution | |
| NL2196012F4P | In distribution | |
| NL1064024F4P | In distribution | |
| NL192026F11M | In distribution | |
| NL1192024F4P | In distribution | |
| NL260137F4P | In distribution | |
| NL86800,7E9P | In distribution | |
| NL260125B2P | In distribution | |
| NL1064018F2P | In distribution | |
| NL761000,4F0P | In distribution | |
| NL166015F4P | In distribution | |
| NL1062035F4P | In distribution | |
| NL1164019F4P | In distribution | |
| NL173060A2P | In distribution | |
| NL262030F4P | In distribution | |
| NL265019F4P | In distribution | |
| NL1165020F9P | In distribution | |
| NL263016A4P | In distribution | |
| NL362060F2P | In distribution | |
| NL963021F4P | In distribution | |
| NL89800,9B13M | In distribution | |
| NL86600,65F7P | In distribution | |
| NL262026F6P | In distribution | |
| NL264030F0P | In distribution | |
| NL761000,6B9P | In distribution | |
| NL195016F13M | In distribution | |
| NL360145B4P | In distribution | |
| NL1160190F4P | In distribution | |
| NL1092039F4P | In distribution | |
| NL292031B0P | In distribution | |
| NL390290F2P | In distribution | |
| NL290026F4P | In distribution | |
| NL590150B0P | In distribution | |
| NL160025F0P | In distribution | |
| NL1062060A2P | In distribution | |
| NL1093063A4P | In distribution | |
| NL560148BI1P | In distribution | |
| NL164019F11M | In distribution | |
| NL1163030B0P | In distribution | |
| NL164012F13M | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Trelon | B Braun Surgical SA | 72 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023028 | 2003-06-18 |
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.