DemeSORB
Absorbable, Synthetic, Polyglycolic acid Suture
4manufacturers in China registered for this device type
1,625catalogue numbers in this listing
3510(k) clearances naming this product code
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 | Demetech Corp., 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, Complaint-file establishment, Manufacturer |
| 510(k) | K043539 |
| Record published | 2019-07-24 |
| Record revised | 2025-09-26 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PGA5x680140B0P | In distribution | |
| PGA1080040B0P | In distribution | |
| PGA1682036B0P | In distribution | |
| PGA282026B6P | In distribution | |
| PGA270036B5P | In distribution | |
| PGA282027B0P | In distribution | |
| PGA1185015B0P | In distribution | |
| PGA275022B0P | In distribution | |
| PGA272040B0P | In distribution | |
| PGA1080120B0P | In distribution | |
| PGA1174024F4P | In distribution | |
| PGA280230F2P | In distribution | |
| PGA5x11840 | In distribution | |
| PGA280080B6P | In distribution | |
| PGA1070136B0P | In distribution | |
| PGA380150B6P | In distribution | |
| PGA272026B16P | In distribution | |
| PGA184024F4P | In distribution | |
| PGA275016F4P | In distribution | |
| PGA382030C0P | In distribution | |
| PGA1085020B0P | In distribution | |
| PGA1184026B6P | In distribution | |
| PGA283025F4P | In distribution | |
| PGA1080245B16P | In distribution | |
| PGA183035B0P | In distribution | |
| PGA1082035B0P | In distribution | |
| PGA280126B0P | In distribution | |
| PGA186011F4P | In distribution | |
| PGA272036B0P | In distribution | |
| PGA25800 | In distribution | |
| PGA88800,65C7P | In distribution | |
| PGA180040B0P | In distribution | |
| PGA283026F2P | In distribution | |
| PGA273026B0P | In distribution | |
| PGA272040B1P | In distribution | |
| PGA1083027B0P | In distribution | |
| PGA5x183026B0P | In distribution | |
| PGA284017B0P | In distribution | |
| PGA280036H0P | In distribution | |
| PGA282037F2P | In distribution | |
| PGA280136B4P | In distribution | |
| PGA1080036B1P | In distribution | |
| PGA286015B0P | In distribution | |
| PGA284021B0P | In distribution | |
| PGA280038B0P | In distribution | |
| PGA280237B0P | In distribution | |
| PGA1084019B0P | In distribution | |
| PGA186012F2P | In distribution | |
| PGA180045B0P | In distribution | |
| PGA182030B0P | In distribution | |
| PGA176013B0P | In distribution | |
| PGA280045B6P | In distribution | |
| PGA173026F11M | In distribution | |
| PGA173019F2P | In distribution | |
| PGA284022F2P | In distribution | |
| PGA283019F4P | In distribution | |
| PGA182020F4P | In distribution | |
| PGA176016F13M | In distribution | |
| PGA280135B0P | In distribution | |
| PGA174019F2P | In distribution | |
| PGA1980265BI0P | In distribution | |
| PGA280227F2P | In distribution | |
| PGA282039F4P | In distribution | |
| PGA3x1720 | In distribution | |
| PGA2820 | In distribution | |
| PGA18500,8F7P | In distribution | |
| PGA380140B6P | In distribution | |
| PGA280036B6P | In distribution | |
| PGA282030F4P | In distribution | |
| PGA6x1850 | In distribution | |
| PGA1183031B0P | In distribution | |
| PGA10X2800 | In distribution | |
| PGA18800,8G14P | In distribution | |
| PGA1183026B0P | In distribution | |
| PGA282017F2P | In distribution | |
| PGA273017F6P | In distribution | |
| PGA186017B0P | In distribution | |
| PGA270026B1P | In distribution | |
| PGA1186017B0P | In distribution | |
| PGA148600,8E7P | In distribution | |
| PGA284018F2P | In distribution | |
| PGA6x2802 | In distribution | |
| PGA1082022B0P | In distribution | |
| PGA284026B4P | In distribution | |
| PGA3x180022B5P | In distribution | |
| PGA1180137B1P | In distribution | |
| PGA283019B0P | In distribution | |
| PGA186019F4P | In distribution | |
| PGA280148B1P | In distribution | |
| PGA280030F4P | In distribution | |
| PGA273019F11M | In distribution | |
| PGA283019B6P | In distribution | |
| PGA1183036B0P | In distribution | |
| PGA173019F11M | In distribution | |
| PGA280145B4P | In distribution | |
| PGA183026B0P | In distribution | |
| PGA1082037B0P | In distribution | |
| PGA176011B13M | In distribution | |
| PGA282026B4P | In distribution | |
| PGA882023J0P | In distribution | |
| PGA28600,8B0P | In distribution | |
| PGA1082025C0P | In distribution | |
| PGA283016F4P | In distribution | |
| PGA2x11830 | In distribution | |
| PGA274022B0P | In distribution | |
| PGA1183037B0P | In distribution | |
| PGA88800,65F7P | In distribution | |
| PGA280236B6P | In distribution | |
| PGA1080148B16P | In distribution | |
| PGA1082048B1P | In distribution | |
| PGA285013B0P | In distribution | |
| PGA5x11800 | In distribution | |
| PGA25820 | In distribution | |
| PGA3x180122B4P | In distribution | |
| PGA280250F4P | In distribution | |
| PGA280045B4P | In distribution | |
| PGA282040B16P | In distribution | |
| PGA1180020B0P | In distribution | |
| PGA11800 | In distribution | |
| PGA280031J0P | In distribution | |
| PGA185012B4P | In distribution | |
| PGA1185017B0P | In distribution | |
| PGA184026F4P | In distribution | |
| PGA284017F4P | In distribution | |
| PGA274024F13M | In distribution | |
| PGA272030F13M | In distribution | |
| PGA183016F4P | In distribution | |
| PGA1173024F13M | In distribution | |
| PGA1080026B1P | In distribution | |
| PGA1182030F4P | In distribution | |
| PGA18600,9E9P | In distribution | |
| PGA185015B0P | In distribution | |
| PGA280150B0P | In distribution | |
| PGA280150F0P | In distribution | |
| PGA283035F4P | In distribution | |
| PGA182026B0P | In distribution | |
| PGA1484022F0P | In distribution | |
| PGA1083018B0P | In distribution | |
| PGA280030B6P | In distribution | |
| PGA1182025F4P | In distribution | |
| PGA1181025B0P | In distribution | |
| PGA275017F6P | In distribution | |
| PGA673019F13M | In distribution | |
| PGA1083036B0P | In distribution | |
| PGA1080260B1P | In distribution | |
| PGA184011A4P | In distribution | |
| PGA272036F11M | In distribution | |
| PGA18600,65G7P | In distribution | |
| PGA275019F4P | In distribution | |
| PGA280248B1P | In distribution | |
| PGA176013B13M | In distribution | |
| PGA12x1820 | In distribution | |
| PGA3x1730 | In distribution | |
| PGA175012F4P | In distribution | |
| PGA3x1830 | In distribution | |
| PGA1720 | In distribution | |
| PGA1180030B0P | In distribution | |
| PGA1774013F13M | In distribution | |
| PGA183019B4P | In distribution | |
| PGA1080245B0P | In distribution | |
| PGA2x11820 | In distribution | |
| PGA580148B0P | In distribution | |
| PGA280237F2P | In distribution | |
| PGA180140B0P | In distribution | |
| PGA1070036B6P | In distribution | |
| PGA270037B1P | In distribution | |
| PGA282037F4P | In distribution | |
| PGA280037B0P | In distribution | |
| PGA18500,65G7P | In distribution | |
| PGA174011F13M | In distribution | |
| PGA1080140B20P | In distribution | |
| PGA274019F11M | In distribution | |
| PGA274026F4P | In distribution | |
| PGA280026F4P | In distribution | |
| PGA174013B0P | In distribution | |
| PGA282036B16P | In distribution | |
| PGA282060A4P | In distribution | |
| PGA1080137B6P | In distribution | |
| PGA3x182022B5P | In distribution | |
| PGA1172040B4P | In distribution | |
| PGA1086010B0P | In distribution | |
| PGA282027F4P | In distribution | |
| PGA286010B0P | In distribution | |
| PGA284016F2P | In distribution | |
| PGA4x1180136B0P | In distribution | |
| PGA280222F4P | In distribution | |
| PGA5X2820 | In distribution | |
| PGA184017F0P | In distribution | |
| PGA280146B0P | In distribution | |
| PGA280127B0P | In distribution | |
| PGA6x1802 | In distribution | |
| PGA186013F13M | In distribution | |
| PGA385017F4P | In distribution | |
| PGA1176019F4P | In distribution | |
| PGA283031B0P | In distribution | |
| PGA18600,65D7P | In distribution | |
| PGA283040B0P | In distribution | |
| PGA282026B0VB | In distribution | |
| PGA280024F2P | In distribution | |
| PGA283035B0P | In distribution | |
| PGA5x2801 | In distribution | |
| PGA280124B4P | In distribution | |
| PGA183016B0P | In distribution | |
| PGA272022B5P | In distribution | |
| PGA1180236B0P | In distribution | |
| PGA284020F4P | In distribution | |
| PGA280037B1P | In distribution | |
| PGA270136B0P | In distribution | |
| PGA1182022B0P | In distribution | |
| PGA1080240B4P | In distribution | |
| PGA283026B2P | In distribution | |
| PGA186012F4P | In distribution | |
| PGA184019F4P | In distribution | |
| PGA283024F0P | In distribution | |
| PGA280138B0P | In distribution | |
| PGA1181037B0P | In distribution | |
| PGA1184026B0P | In distribution | |
| PGA283040F2P | In distribution | |
| PGA173016F4P | In distribution | |
| PGA280248B0P | In distribution | |
| PGA1080140H0P | In distribution | |
| PGA1080148B4P | In distribution | |
| PGA383040A4P | In distribution | |
| PGA280019B0P | In distribution | |
| PGA286011B0P | In distribution | |
| PGA17400,8B13M | In distribution | |
| PGA283035B4P | In distribution | |
| PGA185026B0P | In distribution | |
| PGA184025F4P | In distribution | |
| PGA280240B4P | In distribution | |
| PGA272036B4P | In distribution | |
| PGA173026F13M | In distribution | |
| PGA272024F13M | In distribution | |
| PGA16801 | In distribution | |
| PGA580037BI0P | In distribution | |
| PGA1080236B0P | In distribution | |
| PGA186016F4P | In distribution | |
| PGA184013A2P | In distribution | |
| PGA280020B0P | In distribution | |
| PGA1183023B0P | In distribution | |
| PGA18500,65D9P | In distribution | |
| PGR1672036C4P | In distribution | |
| PGA280125B0P | In distribution | |
| PGA283018F4P | In distribution | |
| PGA280050B4P | In distribution | |
| PGA1180036B6P | In distribution | |
| PGA272027B1P | In distribution | |
| PGA381040B0P | In distribution | |
| PGA270122B5P | In distribution | |
| PGA280130F2P | 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 |
| 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 |
| Atramat | Internacional Farmacéutica S.A DE C.V | 319 |
Showing 12 of 463. All products under Suture, Absorbable, Synthetic, Polyglycolic Acid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123940 | 2014-05-30 |
| K130083 | 2013-07-17 |
| K043539 | 2005-04-06 |
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.