Hu-Friedy Mfg. Co., LLC
5-0 Undyed Pgafa Suture 18", C-1 Needle 10.7 MM, 3/8 Circle Premium Reverse CUT
4manufacturers in China registered for this device type
32catalogue 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 | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-10-16 |
| Record revised | 2024-11-11 (version 5) |
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, bag of 3 |
| Distribution end date | 2022-01-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSN271V | 4-0 | In distribution |
| PSN304V | 4-0 | In distribution |
| PSN494V | 4-0 | In distribution |
| PSN489V | 6-0 | In distribution |
| PSN585FA | 3-0 | In distribution |
| PSN493V | 5-0 | In distribution |
| PSN530FA | 5-0 | In distribution |
| PSN302V | 6-0 | In distribution |
| PSN490V | 5-0 | In distribution |
| PSN303V | 5-0 | In distribution |
| PSN723V | 5-0 | In distribution |
| PSN515FA | 5-0 | In distribution |
| PSN540FA | 3-0 | In distribution |
| PSN422V | 4-0 | In distribution |
| PSN397V | 4-0 | In distribution |
| PSN421V | 5-0 | In distribution |
| PSN388V | In distribution | |
| PSN724V | 4-0 | In distribution |
| PSN535FA | 4-0 | In distribution |
| PSN389V | 4-0 | In distribution |
| PSN525FA | 4-0 | In distribution |
| PSN492V | 6-0 | In distribution |
| PSN386V | 4-0 | In distribution |
| PSN393V | 3-0 | In distribution |
| PSN510FA | 4-0 | In distribution |
| PSN392V | 4-0 | In distribution |
| PSN387V | 6-0 | In distribution |
| PSN460V | 3-0 | In distribution |
| PSN385V | 5-0 | In distribution |
| PSN520FA | 3-0 | Withdrawn |
| PSN505FA | 5-0 | Withdrawn |
| PSN305V | 3-0 | Withdrawn |
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.