Unify PGA Surgical Sutures
UNIFY PGA Ultra-Premium Microsutures, Size 6-0, Braided Coated, 6.4mm 3/8 Cir Spatula, Double, 12"
4manufacturers in China registered for this device type
54catalogue 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 | Applied Dental, Inc. |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| 510(k) | K073614 |
| Record published | 2015-08-21 |
| Record revised | 2021-02-05 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, case of 100, box of 36, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S-G418R13 | In distribution | |
| XL-G030T36 | In distribution | |
| M-G330T17 | In distribution | |
| L-G330R24 | In distribution | |
| M-G318R19 | In distribution | |
| XXS-G612S6D | In distribution | |
| M-G418A16 | In distribution | |
| S-G518R13 | In distribution | |
| M-G318XR19 | In distribution | |
| XXL-1G30R40 | In distribution | |
| XXS-G812S6D | In distribution | |
| M-G430R19 | In distribution | |
| M-G418R19 | In distribution | |
| XL-G230T36 | In distribution | |
| M-G418R19-U | In distribution | |
| M-G518R19 | In distribution | |
| M-G430T17 | In distribution | |
| M-G418R16-U | In distribution | |
| M-G330T17-U | In distribution | |
| M-G518R16-U | In distribution | |
| L-G330T26-U | In distribution | |
| M-G418XR19-U | In distribution | |
| L-G330T26 | In distribution | |
| M-G518A16-U | In distribution | |
| M-G418R16 | In distribution | |
| M-G418A16-U | In distribution | |
| S-G618R13-U | In distribution | |
| M-G518R19-U | In distribution | |
| XL-G030R30 | In distribution | |
| L-G230T26 | In distribution | |
| M-G330R19 | In distribution | |
| M-G430R19-U | In distribution | |
| S-G518XR13-U | In distribution | |
| M-G418XR19 | In distribution | |
| S-G418R13-U | In distribution | |
| XL-G230T36-U | In distribution | |
| M-G330R19-U | In distribution | |
| M-G430T17-U | In distribution | |
| L-G230T26-U | In distribution | |
| L-G330R24-U | In distribution | |
| XS-G718R11 | In distribution | |
| S-G618R13 | In distribution | |
| S-G418XR13 | In distribution | |
| S-G518R13-U | In distribution | |
| S-G418XR13-U | In distribution | |
| M-G318R19-U | In distribution | |
| XS-G618R11-U | In distribution | |
| L-G230R24 | In distribution | |
| M-G518R16 | In distribution | |
| M-G518A16 | In distribution | |
| M-G318XR19-U | In distribution | |
| S-G518XR13-U | In distribution | |
| XS-G518R11-U | In distribution | |
| L-G230R24-U | 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.