Atramat
Atramat PGLA90 Surgical Suture Undyed USP 4-0 EP 1,5, 45 CM Needle P-PE-19 Supra-Sharp Reverse Cutting 19 MM 3/8 Circle PGLA90 Incoloro USP 4-0, 45 CM Aguja P-PE-19 Reverso Cortante…
Atramat PGLA90 Surgical Suture Undyed USP 4-0 EP 1,5, 45 CM Needle P-PE-19 Supra-Sharp Reverse Cutting 19 MM 3/8 Circle PGLA90 Incoloro USP 4-0, 45 CM Aguja P-PE-19 Reverso Cortante Supra-Sharp 19 MM 3/8 Circulo
4manufacturers in China registered for this device type
319catalogue numbers in this listing
1510(k) clearance
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 | Internacional Farmacéutica S.A DE C.V, Mexico |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| 510(k) | K072859 |
| Record published | 2016-10-14 |
| Record revised | 2021-02-05 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 65 % RH |
| Packaging | Dozen of 12, box with 36 packs of 36, pack of 12, 07500142113437 of 12, 07500142147166 of 12, 12 of 12 |
| Sizes | Length 6 to 65 mm; length 50 cm |
| Distribution end date | 2029-10-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PGLA90 | Length 19 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGLA90 | Length 6.5 mm | In distribution |
| PGA RAPID | Length 26 mm | In distribution |
| PGC25 | Length 16 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGLA90 | Length 17 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGLA 90 | Length 26 mm | In distribution |
| PGC25 | Length 24 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGLA90 | Length 40 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGLA90 | Length 8 mm | In distribution |
| PCG25 | Length 19 mm | In distribution |
| PGA | Length 20 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGC25 | Length 24 mm | In distribution |
| PGA | Length 40 mm | In distribution |
| PGA | USP 2-0 EP 3 | In distribution |
| PGA | Length 24 mm | In distribution |
| PGA RAPID | Length 36 mm | In distribution |
| PGC25 | Length 40 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA RAPID | Length 37 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGLA90 | Length 17 mm | In distribution |
| PGC25 | Length 17 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGA | Length 20 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA RAPID | Length 24 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGLA90 | Length 19 mm | In distribution |
| PGLA 90 | Length 19 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 6 mm | In distribution |
| PGA | Length 16 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGLA90 | Length 11 mm | In distribution |
| PGC25 | Length 30 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGA | Length 17 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGA RAPID | Length 40 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PLAIN GUT | Length 19 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGC25 | Length 36 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGLA90 | Length 16 mm | In distribution |
| PGA | Length 11 mm | In distribution |
| PGA | USP 1 EP 4 | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGC25 | 1/2 CIRCLE | In distribution |
| PGA | Length 26 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGLA90 | Length 13 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGLA90 | Length 40 mm | In distribution |
| PGA | Length 13 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGA RAPID | USP 2-0 EP 3 | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGA | Length 6 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGA | Length 13 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA | Length 13 mm | In distribution |
| PGA RAPID | Length 36 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGC25 | Length 24 mm | In distribution |
| PGLA90 | Length 6 mm | In distribution |
| PGA | Length 20 mm | In distribution |
| PGC25 | Length 40 mm | In distribution |
| PGLA90 | Length 17 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA RAPID | Length 13 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGC25 | Length 24 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 11 mm | In distribution |
| PGA | Length 48 mm | In distribution |
| PGA | Length 17 mm | In distribution |
| PGA RAPID | Length 26 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGA | WITHOUT NEEDLE | In distribution |
| PGA | Length 40 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGLA90 | Length 16 mm | In distribution |
| PGA RAPID | Length 26 mm | In distribution |
| PGA | Length 17 mm | In distribution |
| PGC25 | Length 24 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGLA90 | Length 20 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 40 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGA | Length 24 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGLA90 | Length 20 mm | In distribution |
| PGA | Length 17 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGLA90 | Length 19 mm | In distribution |
| PGLA90 | Length 19 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGLA90 | Length 17 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA RAPID | Length 14 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGC25 | Length 17 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA | Length 60 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGLA 90 | Length 36 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGC25 | 1/2 CIRCLE | In distribution |
| PGA | Length 30 mm | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGLA90 | Length 13 mm | In distribution |
| PGLA90 | Length 36 mm | In distribution |
| PGA | Length 40 mm | In distribution |
| PGLA90 | Length 48 mm | In distribution |
| PGA | Length 17 mm | In distribution |
| PGC25 | 1/2 CIRCLE | In distribution |
| PGLA90 | Length 19 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGC25 | Length 36 mm | In distribution |
| PGA | Length 40 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 30 mm | In distribution |
| PGLA90 | Length 17 mm | In distribution |
| PGA RAPID | Length 17 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGA | Length 13 mm | In distribution |
| PGA | Length 20 mm | In distribution |
| PGA | Length 13 mm | In distribution |
| PGLA90 | Length 40 mm | In distribution |
| PGLA90 | Length 24 mm | In distribution |
| PGA | USP 4-0 | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGA | Length 16 mm | In distribution |
| PGLA90 | USP 3-0 EP 2 | In distribution |
| PGC25 | 1/2 CIRCLE | In distribution |
| PGA | Length 24 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGLA 90 | Length 16 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGLA90 | Length 48 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGA | Length 19 mm | In distribution |
| PGA | WITHOUT NEEDLE | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGLA90 | Length 24 mm | In distribution |
| PGLA90 | Length 13 mm | In distribution |
| PGC25 | Length 26 mm | In distribution |
| PGA | Length 13 mm | In distribution |
| PGLA90 | Length 19 mm | In distribution |
| PGLA90 | Length 19 mm | In distribution |
| PGA | Length 40 mm | In distribution |
| PGA | Length 37 mm | In distribution |
| PGA | Length 36 mm | In distribution |
| PGA | Length 12 mm | In distribution |
| PGA | Length 50 cm | In distribution |
| PGA | Length 17 mm | In distribution |
| PGC25 | Length 11 mm | In distribution |
| PGC25 | Length 19 mm | In distribution |
| PGA | WITHOUT NEEDLE | In distribution |
| PGC25 | Length 13 mm | In distribution |
| PGA | Length 6 mm | In distribution |
| PGA | Length 60 mm | In distribution |
| PGC25 | Length 11 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGA | Length 26 mm | In distribution |
| PGLA90 | Length 22 mm | In distribution |
| PGLA90 | Length 48 mm | In distribution |
| PGA | Length 8 mm | In distribution |
| PGC25 | 1/2 CIRCLE | In distribution |
| PGLA90 | Length 26 mm | In distribution |
| PGA | Length 37 mm | In distribution |
Showing 250 of 300 catalogue numbers.
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252820 | 2025-10-03 |
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.