Onatec
Onalon Nylon 7-0, 1 arm(s) HDK-8,0-230 P 7/0 30 cm loop Nylon
3manufacturers in China registered for this device type
75catalogue 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 | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| Record published | 2022-04-25 |
| Record revised | 2025-08-13 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OL351160 | In distribution | |
| OL145170 | In distribution | |
| OS351303 | In distribution | |
| OL311830 | In distribution | |
| OL456210 | In distribution | |
| OL456290 | In distribution | |
| OL145081 | In distribution | |
| OL318061 | In distribution | |
| OL466460 | In distribution | |
| OL495591 | In distribution | |
| OL318060 | In distribution | |
| OL351930 | In distribution | |
| OL456291 | In distribution | |
| OL349551 | In distribution | |
| OL456280 | In distribution | |
| OL144890 | In distribution | |
| OL351630 | In distribution | |
| OL341351 | In distribution | |
| OL145091 | In distribution | |
| OL351340 | In distribution | |
| OS351330 | In distribution | |
| OL351155 | In distribution | |
| OL415581 | In distribution | |
| OL351150 | In distribution | |
| OL145191 | In distribution | |
| OL146480 | In distribution | |
| OL456292 | In distribution | |
| OL415080 | In distribution | |
| OL318045 | In distribution | |
| OL415691 | In distribution | |
| OL456471 | In distribution | |
| OL144091 | In distribution | |
| OL417091 | In distribution | |
| OL351640 | In distribution | |
| OL245180 | In distribution | |
| OL456692 | In distribution | |
| OL144011 | In distribution | |
| OS351304 | In distribution | |
| OL249450 | In distribution | |
| OS351630 | In distribution | |
| OL144010 | In distribution | |
| OL245190 | In distribution | |
| OL351330 | In distribution | |
| OL456270 | In distribution | |
| OL246590 | In distribution | |
| OL351335 | In distribution | |
| OL415695 | In distribution | |
| OL145190 | In distribution | |
| OS351603 | In distribution | |
| OL456481 | In distribution | |
| OL351650 | In distribution | |
| OL145180 | In distribution | |
| OL456292 | In distribution | |
| OL456285 | In distribution | |
| OL494891 | In distribution | |
| OL464895 | In distribution | |
| OL415591 | In distribution | |
| OL211830 | In distribution | |
| OS351150 | In distribution | |
| OL468545 | In distribution | |
| OL351350 | In distribution | |
| OL318055 | In distribution | |
| OL494895 | In distribution | |
| OL415681 | In distribution | |
| OL146490 | In distribution | |
| OL415592 | In distribution | |
| OL468041 | In distribution | |
| OL341161 | In distribution | |
| OL246550 | In distribution | |
| OL145195 | In distribution | |
| OL341151 | In distribution | |
| OL456281 | In distribution | |
| OL415690 | In distribution | |
| OL146470 | In distribution | |
| OL456295 | 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 |
| 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
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.