Onatec
Onalene 1 arm(s),DLZL-6,2-150 9/0 10 cm PP blue,GLZL-16-150 9/0 10 cm PP blue
3manufacturers in China registered for this device type
41catalogue 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 | Surgical Specialties México, S. de R.L. de C.V. |
|---|---|
| FDA product code | GAW |
| Device type | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5010 |
| Record published | 2022-04-27 |
| Record revised | 2024-11-11 (version 4) |
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 |
| Packaging | Box of 12, box of 5, pack of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OE347860 | In distribution | |
| OE145190 | In distribution | |
| OE456465 | In distribution | |
| OE471680 | In distribution | |
| OE490096 | In distribution | |
| OE491695 | In distribution | |
| OE481681 | In distribution | |
| OE347865 | In distribution | |
| OE471675 | In distribution | |
| OE352520 | In distribution | |
| OE172090 | In distribution | |
| OE461981 | 9-0 USP | In distribution |
| OE455590 | In distribution | |
| OE471690 | In distribution | |
| OE172080 | In distribution | |
| OEX1 | In distribution | |
| OE249465 | In distribution | |
| OE249455 | In distribution | |
| OE481691 | In distribution | |
| OE172081 | 9-0 USP | In distribution |
| OE347867 | In distribution | |
| OE261391 | In distribution | |
| OE471691 | In distribution | |
| OE347850 | In distribution | |
| OE490085 | In distribution | |
| OE416045 | In distribution | |
| OE461980 | In distribution | |
| OE471681 | In distribution | |
| OE347866 | In distribution | |
| OE461690 | In distribution | |
| OE461996 | 10-0 USP | In distribution |
| OE245685 | In distribution | |
| OE461382 | In distribution | |
| OE172091 | 10-0 USP | In distribution |
| OE491685 | In distribution | |
| OE341161 | In distribution | |
| OE461995 | In distribution | |
| OE341251 | In distribution | |
| OE471695 | In distribution | |
| OE341331 | In distribution | |
| OE461980 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLENE | Demetech Corp. | 1,707 |
| 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 |
Showing 12 of 200. All products under Suture, Nonabsorbable, Synthetic, Polypropylene
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.