Onatec
Onasorb 2 arm(s) STRABOS 2xVLZL-8,0-350 6/0 45 cm PGA violet
4manufacturers in China registered for this device type
76catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Sichuan Innovation Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 2 |
Record
| Listed by | Surgical Specialties México, S. de R.L. de C.V. |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Record published | 2025-06-02 |
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 |
|---|---|---|
| ON146571 | In distribution | |
| ON468058 | In distribution | |
| GA-1155N | In distribution | |
| ON455595 | In distribution | |
| ON454081 | In distribution | |
| ON341332 | In distribution | |
| ON456470 | In distribution | |
| ON351155 | In distribution | |
| ON351930 | In distribution | |
| ON146485 | In distribution | |
| ON456455 | In distribution | |
| ON456460 | In distribution | |
| ON347855 | In distribution | |
| ON351347 | In distribution | |
| ON456661 | In distribution | |
| ON245071 | In distribution | |
| ON145190 | In distribution | |
| ON347870 | In distribution | |
| ON415595 | In distribution | |
| ON416451 | In distribution | |
| ON456485 | In distribution | |
| ON244081 | In distribution | |
| ON468541 | In distribution | |
| ON456490 | In distribution | |
| ON454095 | In distribution | |
| ON415580 | In distribution | |
| ON456495 | In distribution | |
| ON455595 | In distribution | |
| ON211345 | In distribution | |
| ON456476 | In distribution | |
| ON468035 | In distribution | |
| ON468155 | In distribution | |
| ON468055 | In distribution | |
| ON347871 | In distribution | |
| ON111732 | In distribution | |
| ON347850 | In distribution | |
| ON456481 | In distribution | |
| ON351150 | In distribution | |
| ON454096 | In distribution | |
| ON116460 | In distribution | |
| ON456466 | In distribution | |
| ON351140 | In distribution | |
| ON468045 | In distribution | |
| ON456465 | In distribution | |
| ON458055 | In distribution | |
| ON146470 | In distribution | |
| ON351340 | In distribution | |
| ON468057 | In distribution | |
| ON466451 | In distribution | |
| ON418045 | In distribution | |
| ON456291 | In distribution | |
| ON455590 | In distribution | |
| ON415575 | In distribution | |
| ON468556 | In distribution | |
| ON468056 | In distribution | |
| ON351640 | In distribution | |
| ON468551 | In distribution | |
| ON468157 | In distribution | |
| ON351156 | In distribution | |
| ON468059 | In distribution | |
| ON351346 | In distribution | |
| ON468545 | In distribution | |
| ON347861 | In distribution | |
| ON468546 | In distribution | |
| ON418056 | In distribution | |
| ON456480 | In distribution | |
| ON456450 | In distribution | |
| ON246570 | In distribution | |
| ON468555 | In distribution | |
| ON456671 | In distribution | |
| ON351330 | In distribution | |
| ON468156 | In distribution | |
| OL416691 | In distribution | |
| ON171934 | In distribution | |
| ON456475 | In distribution | |
| ON241155 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Novosyn | B Braun Surgical SA | 2,286 |
| DemeCRYL | Demetech Corp. | 2,092 |
| DemeSORB | Demetech Corp. | 1,625 |
| Safil | B Braun Surgical SA | 1,613 |
| Monosyn | B Braun Surgical SA | 1,096 |
| E-Pack | Ethicon, Inc. | 967 |
| Coated Vicryl | Ethicon, Inc. | 933 |
| DemeQUICK | Demetech Corp. | 732 |
| Polysorb | Covidien LP | 732 |
| DemeCAPRONE | Demetech Corp. | 707 |
| Wego-PGA Absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 554 |
| Safil Quick+ | B Braun Surgical SA | 414 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
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 |
|---|---|---|---|
| P840051 | 1989-06-07 | MAXON(TM) POLYGLYCONATE MONOFILAMENT ABSORBABLE SU | Davis & Geck, Inc. |
| N18387 | 1987-06-18 | PDS(TM) SUTURE (CLEAR) | Ethicon, Inc. |
| N16881 | 1981-12-04 | DEXON | 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.