Dupaque®
4 in X 4 in, 12-ply, 20 X 10 mesh gauze sponge banded in 10s, which contains an X-ray detectable monofilament. Non-Sterile.
Who Else Makes It
Concentrated in Jiangsu (18), Hubei (13), Zhejiang (12). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Zhejiang Aoki Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Qingdao Likangyuan Medical Device Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 14 |
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | Hubei | Contract manufacturer | 13 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 67. All 67 manufacturers in China registered for Gauze/Sponge, Internal, X-Ray Detectable
Record
| Listed by | Derma Sciences Canada, Inc., Canada |
|---|---|
| FDA product code | GDY |
| Device type | Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4450 |
| Premarket notification | Exempt |
| Record published | 2018-10-23 |
| Record revised | 2024-06-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 8, case of 128, case of 80 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 94814 | 8 in X 4 in | 10 | In distribution |
| 94812 | 8 in X 4 in | 10 | In distribution |
| 2524 | 4 in X 4 in | In distribution | |
| 9463S-5 | 10 cm X 10 cm | 256 | In distribution |
| 94414 | 10 cm X 10 cm | In distribution | |
| 9464S | 4 in X 4 in | 10 | In distribution |
| 94412 | 4 in X 4 in | In distribution | |
| 9463S | 4 in X 4 in | 16 | In distribution |
| 94408 | 4 in X 4 in | In distribution | |
| 9469S | 8 in X 4 in | 10 | In distribution |
| 9460S | 3 in X 3 in | 16 | In distribution |
| 2527 | 4 in X 8 in | In distribution | |
| 9464S-5 | 4 in X 4 in | 256 | In distribution |
| 94416 | 4 in X 4 in | In distribution | |
| 9466S | 4 in X 4 in | 120 | In distribution |
| 9467S | 10 cm X 20 cm | 10 | In distribution |
| 94815 | 20 cm X 10 cm | 30 | In distribution |
| 9467S-5 | 8 in X 4 in | 160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMD-Ritmed | AMD Medicom Inc. | 248 |
| DeRoyal | Deroyal Industries, Inc. | 172 |
| Situate | Covidien LP | 60 |
| Medical Action Industries | Medical Action Industries, Inc. | 58 |
| SurgiCount Safety-Sponge | Stryker GmbH | 50 |
| Dermapac, Inc. | Dermapac Inc. | 48 |
| Surgicount | Stryker GmbH | 48 |
| Dukal | Dukal LLC | 46 |
| Medline | Medline Industries, Inc. | 41 |
| ORLocate | Steris Corporation | 35 |
| A Plus | A Plus International, Inc | 33 |
| Pilling | Teleflex Medical LLC | 31 |
Showing 12 of 82. All products under Gauze/Sponge, Internal, X-Ray Detectable
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.