DemeLENE
Synthetic (polypropylene), Non Absorbable Suture
3manufacturers in China registered for this device type
1,707catalogue 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 | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K043330 |
| Record published | 2019-06-28 |
| Record revised | 2025-09-29 (version 10) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PM295013C0VB | In distribution | |
| PM492036C0P | In distribution | |
| PM1093027C0P | In distribution | |
| PM290140B4P | In distribution | |
| PM294022B0P | In distribution | |
| PM294013B0P | In distribution | |
| PM1095022B0P | In distribution | |
| PM1192026F2P | In distribution | |
| PM1090148B4P | In distribution | |
| PM192060A4P | In distribution | |
| PM1092026C22M | In distribution | |
| PM393025B0P | In distribution | |
| PM290050B0P | In distribution | |
| PM19600,8F13M | In distribution | |
| PM194019F4P | In distribution | |
| PM392030B0P | In distribution | |
| PM290026F4P | In distribution | |
| PM394019F4P | In distribution | |
| PM290230B4P | In distribution | |
| PM69700,8G0P | In distribution | |
| PM293035B0P | In distribution | |
| PM1094022C6P | In distribution | |
| PM393075A4P | In distribution | |
| PM1096018C0P | In distribution | |
| PM292030B6P | In distribution | |
| PM1193025B2P | In distribution | |
| PM195020F17P | In distribution | |
| PM390225F2P | In distribution | |
| PM1094022G2P | In distribution | |
| PM290048B2P | In distribution | |
| PM695013B0P | In distribution | |
| PM29700,9G0P | In distribution | |
| PM195012F4P | In distribution | |
| PM294015B0P | In distribution | |
| PM1090025C0P | In distribution | |
| PM196016B4P | In distribution | |
| PM290137B4P | In distribution | |
| PM290127B0P | In distribution | |
| PM296017B0P | In distribution | |
| PM295013G0P | In distribution | |
| PM1093025F0P | In distribution | |
| PM195013B13M | In distribution | |
| PM1095024F4P | In distribution | |
| PM22930 | In distribution | |
| PM192022F4P | In distribution | |
| PM295012F0P | In distribution | |
| PM1093026C0P | In distribution | |
| PM29700,9F6P | In distribution | |
| PM1092026G2P | In distribution | |
| PM1094016F2P | In distribution | |
| PM69700,9F0VB | In distribution | |
| PM293025B0P | In distribution | |
| PM392075A4P | In distribution | |
| PM292040F4P | In distribution | |
| PM290226B0P | In distribution | |
| PM1095017C6P | In distribution | |
| PM1093020G2P | In distribution | |
| PM296018B0P | In distribution | |
| PM2x1095013G0P | In distribution | |
| PM294025F2P | In distribution | |
| PM590045F2P | In distribution | |
| PM195013F13M | In distribution | |
| PM294013F13M | In distribution | |
| PM290140B6P | In distribution | |
| PM696012F4P | In distribution | |
| PM1293030C0VB | In distribution | |
| PM290290F4P | In distribution | |
| PM295022B4P | In distribution | |
| PM1096013G0P | In distribution | |
| PM1193024F13M | In distribution | |
| PM175013F13M | In distribution | |
| PM194019F0P | In distribution | |
| PM4X69700,8G0P | In distribution | |
| PM293019F12M | In distribution | |
| PM296011F13M | In distribution | |
| PM259200,65A24P | In distribution | |
| PM29700,9G22M | In distribution | |
| PM8X190026B0QR | In distribution | |
| PM2194012F4P | In distribution | |
| PM390137B0P | In distribution | |
| PM696013G22M | In distribution | |
| PM69500,8G0P | In distribution | |
| PM697010G0VB | In distribution | |
| PM8910013DI22M | In distribution | |
| PM1097011G6P | In distribution | |
| PM292040B0P | In distribution | |
| PM8910016DI22M | In distribution | |
| PM219900,6F7P | In distribution | |
| PM1096016F4P | In distribution | |
| PM291030B0P | In distribution | |
| PM1093031B0P | In distribution | |
| PM291036B0P | In distribution | |
| PM1090140B1P | In distribution | |
| PM1194019F13M | In distribution | |
| PM295016F4P | In distribution | |
| PM1092025B6P | In distribution | |
| PM1093019C0P | In distribution | |
| PM1096015G2P | In distribution | |
| PM1491000,8E9P | In distribution | |
| PM174013F13M | In distribution | |
| PM293016C0P | In distribution | |
| PM293026F13M | In distribution | |
| PM193025F2P | In distribution | |
| PM1093036B0P | In distribution | |
| PM194016F19P | In distribution | |
| PM294019G2P | In distribution | |
| PM1190030B0P | In distribution | |
| PM1095017C0VB | In distribution | |
| PM17x1901 | In distribution | |
| PM590148B0P | In distribution | |
| PM29600,8G0VB | In distribution | |
| PM1095017C0P | In distribution | |
| PM192016B0P | In distribution | |
| PM293026F11M | In distribution | |
| PM692030B0P | In distribution | |
| PM390245B0P | In distribution | |
| PM195019F13M | In distribution | |
| PM1090024F4P | In distribution | |
| PM293016B13M | In distribution | |
| PM293022B0P | In distribution | |
| PM1092017B6P | In distribution | |
| PM1093026C6P | In distribution | |
| PM293030C0P | In distribution | |
| PM1194016F4P | In distribution | |
| PM294022G2P | In distribution | |
| PM694013C0P | In distribution | |
| PM293036B0P | In distribution | |
| PM1092025C0P | In distribution | |
| PM296013F22M | In distribution | |
| PM292017G0P | In distribution | |
| PM295022C6P | In distribution | |
| PM19800,9F0P | In distribution | |
| PM2191000,65G7P | In distribution | |
| PM293019F5P | In distribution | |
| PM292019F2P | In distribution | |
| PM1192040B1P | In distribution | |
| PM1094017B0VB | In distribution | |
| PM1094016F13M | In distribution | |
| PM1092036C0P | In distribution | |
| PM590050F2P | In distribution | |
| PM1193024F4P | In distribution | |
| PM1093060A4P | In distribution | |
| PM193022B4P | In distribution | |
| PM196016F2P | In distribution | |
| PM390135B6P | In distribution | |
| PM392040F4P | In distribution | |
| PM590148B13M | In distribution | |
| PM1192026B0P | In distribution | |
| PM390036B4P | In distribution | |
| PM697011G22M | In distribution | |
| PM295019F0P | In distribution | |
| PM1092030F4P | In distribution | |
| PM290150B4P | In distribution | |
| PM292026B4P | In distribution | |
| PM109800,9B0P | In distribution | |
| PM293024F13M | In distribution | |
| PM29600,9G22VB | In distribution | |
| PM290140BI0P | In distribution | |
| PM292020F4P | In distribution | |
| PM390135F2P | In distribution | |
| PM390150B2P | In distribution | |
| PM296015B0P | In distribution | |
| PM195025B0P | In distribution | |
| PM1092030G0P | In distribution | |
| PM290040B6P | In distribution | |
| PM293036F12P | In distribution | |
| PM1095018C0P | In distribution | |
| PM195026F11M | In distribution | |
| PM292045B0P | In distribution | |
| PM690290F4P | In distribution | |
| PM390235B0P | In distribution | |
| PM3x1902 | In distribution | |
| PM295016G6P | In distribution | |
| PM190136B0P | In distribution | |
| PM297013G22M | In distribution | |
| PM194026F11M | In distribution | |
| PM891000,4C9P | In distribution | |
| PM294019F0P | In distribution | |
| PM1094025G2P | In distribution | |
| PM392031B0P | In distribution | |
| PM697011C0P | In distribution | |
| PM1192025B6P | In distribution | |
| PM592026C0P | In distribution | |
| PM69070,9G18VB | In distribution | |
| PM29800,8F0P | In distribution | |
| PM193019F4P | In distribution | |
| PM1093025F4P | In distribution | |
| PM1093036F4P | In distribution | |
| PM293024F2P | In distribution | |
| PM69800,9G0P | In distribution | |
| PM390037F2P | In distribution | |
| PM14910016AX29P | In distribution | |
| PM195016C0P | In distribution | |
| PM1093035G2P | In distribution | |
| PM1097013C0P | In distribution | |
| PM292027F2P | In distribution | |
| PM290145B0P | In distribution | |
| PM293017C0P | In distribution | |
| PM1094028C0P | In distribution | |
| PM69600,8G22M | In distribution | |
| PM695020C0P | In distribution | |
| PM1092030G2P | In distribution | |
| PM292026B0P | In distribution | |
| PM196013F13M | In distribution | |
| PM14910016Ax27P | In distribution | |
| PM1195012F13M | In distribution | |
| PM69600,9G22M | In distribution | |
| PM196017C0P | In distribution | |
| PM1694026C0P | In distribution | |
| PM290165B0P | In distribution | |
| PM1095012F4P | In distribution | |
| PM293025F13M | In distribution | |
| PM1095018B0P | In distribution | |
| PM1093025C6P | In distribution | |
| PM19800,65G7P | In distribution | |
| PM292055A4P | In distribution | |
| PM696010C0P | In distribution | |
| PM1094026C6P | In distribution | |
| PM290040B1P | In distribution | |
| PM196016F4P | In distribution | |
| PM99700,8G0P | In distribution | |
| PM294010F0P | In distribution | |
| PM294017B4P | In distribution | |
| PM194017B4P | In distribution | |
| PM296017B4P | In distribution | |
| PM292017C0P | In distribution | |
| PM69700,9F22M | In distribution | |
| PM1990165BI0P | In distribution | |
| PM390036B20P | In distribution | |
| PM69700,9G6P | In distribution | |
| PM296013F0P | In distribution | |
| PM1095016G2P | In distribution | |
| PM295018F4P | In distribution | |
| PM290026B1P | In distribution | |
| PM29600,8G0P | In distribution | |
| PM696010G4P | In distribution | |
| PM192022F13M | In distribution | |
| PM1095013G0P | In distribution | |
| PM1094030F4P | In distribution | |
| PM1095016C0P | In distribution | |
| PM1194024F2P | In distribution | |
| PM293060A2P | In distribution | |
| PM1095020B0P | In distribution | |
| PM1092040G2P | In distribution | |
| PM1093026B0P | In distribution | |
| PM69600,8G0P | In distribution | |
| PM290130B1P | In distribution | |
| PM195016F13M | In distribution | |
| PM1095019G2P | In distribution | |
| PM392075A2P | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premilene | B Braun Surgical SA | 1,247 |
| Optilene | B Braun Surgical SA | 1,110 |
| Prolene | Ethicon, Inc. | 765 |
| Deknatel | Teleflex Medical LLC | 373 |
| Corolene® | Peters Surgical | 354 |
| WEGO-Polypropylene Nonabsorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 346 |
| Surgipro II | Covidien LP | 254 |
| Surgipro ll | Covidien LP | 152 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 140 |
| Surgipro | Covidien LP | 133 |
| Filaprop | Meril Endo Surgery PVT. Ltd. | 123 |
| Gore-TEX Suture | W. L. Gore & Associates, Inc. | 113 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K043330 | 2005-05-16 |
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 |
|---|---|---|---|
| P890002 | 1989-05-31 | POLYPROPYLENE SURGICAL SUTURE | Alcon Laboratories, Inc. |
| P820083 | 1986-08-05 | GORE-TEX(R) EXPANDED PTFE SUTURE | W. L. Gore & Associates, 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.