McKesson
SUTURE 3-0, PGA-PCL, Undyed Monofilament, U.S.P. except for diameter 3-0 (2.0 Metric) 18"/46cm Synthetic Absorbable Surgical Suture, DSM19 Precision Reverse Cutting 3/8 Circle 19 mm
4manufacturers in China registered for this device type
51catalogue 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 | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | GAM |
| Device type | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4493 |
| 510(k) | K172659 |
| Record published | 2016-12-09 |
| Record revised | 2019-09-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 12, case of 24, box of 36 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SJ497G | In distribution | ||
| M-Y417H | 36 | In distribution | |
| SY427H | In distribution | ||
| SY497G | In distribution | ||
| SJ423H | In distribution | ||
| SZ494G | In distribution | ||
| SY493G | In distribution | ||
| SJ422H | In distribution | ||
| SJ492GX | In distribution | ||
| SJ429G | 12 | In distribution | |
| M-Y463G | 12 | In distribution | |
| SY426H | In distribution | ||
| SJ496GX | In distribution | ||
| M-Y415H | 36 | In distribution | |
| M-Y513G | 12 | In distribution | |
| M-Y426H | 36 | In distribution | |
| M-Y494G | 12 | In distribution | |
| SJ494G | In distribution | ||
| SY496G | In distribution | ||
| M-Y495G | 12 | In distribution | |
| SJ493G | In distribution | ||
| SJ426H | In distribution | ||
| M-Y427H | 36 | In distribution | |
| M-Y464G | 12 | In distribution | |
| SZ497G | In distribution | ||
| SJ417H | In distribution | ||
| SY497GX | In distribution | ||
| M-Y945H | 36 | In distribution | |
| SJ496G | In distribution | ||
| M-Y493G | 12 | In distribution | |
| SY493GX | In distribution | ||
| M-Y497G | 12 | In distribution | |
| SJ421G | In distribution | ||
| SY494GX | In distribution | ||
| M-Y845G | 12 | In distribution | |
| SJ416H | In distribution | ||
| SJ497GX | In distribution | ||
| SY496GX | In distribution | ||
| SJ492G | In distribution | ||
| SJ259H | In distribution | ||
| SJ493GX | In distribution | ||
| SJ421GX | In distribution | ||
| M-Y492G | 12 | In distribution | |
| SJ443H | In distribution | ||
| M-Y416H | 36 | In distribution | |
| M-Y936H | 36 | In distribution | |
| SJ494GX | In distribution | ||
| M-Y496G | 12 | In distribution | |
| SY494G | In distribution | ||
| SJ269H | In distribution | ||
| SJ422G | 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
Recalls Naming This Product
30 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2019-12-18 | Class II | Equipment maintenance | There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific production lots. | 139,938 units total | 2022-08-16 |
| Covidien | 510(k) number | 2017-05-03 | Class II | Process control | Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. | 478,465 (total for all products) | 2019-07-18 |
| Covidien | 510(k) number | 2017-05-03 | Class II | Process control | Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. | 478,465 (total for all products) | 2019-07-18 |
| Covidien | 510(k) number | 2017-05-03 | Class II | Process control | Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material. | 478,465 (total for all products) | 2019-07-18 |
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.