Medical Action Industries
Sponge: Specialty Stick XL 1.25 XR 100/c
67manufacturers in China registered for this device type
58catalogue numbers in this listing
1510(k) clearance
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 | Medical Action Industries, Inc., United States |
|---|---|
| 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 | 2016-08-20 |
| Record revised | 2021-08-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: store at room temperature |
| Packaging | Pack of 40, pack of 100, pack of 20, pack of 50, pack of 5, pack of 4 |
| Distribution end date | 2023-08-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 405 | 5 | In distribution | |
| B250 | 800 | In distribution | |
| 7301 | 10 | In distribution | |
| 408 | 5 | In distribution | |
| 240-V | 800 | In distribution | |
| B7202 | 250 | In distribution | |
| B7102 | 100 | In distribution | |
| 207 | 200 | In distribution | |
| 307 | 5 | In distribution | |
| 407 | 5 | In distribution | |
| 254 | 800 | In distribution | |
| 400 | 5 | In distribution | |
| 7201 | 5 | In distribution | |
| 7207 | 5 | In distribution | |
| 411 | 5 | In distribution | |
| SM4111R | 5 | In distribution | |
| 403 | 5 | In distribution | |
| B7400 | 500 | In distribution | |
| B7201 | 5 | In distribution | |
| 7202 | 5 | In distribution | |
| 404 | 5 | In distribution | |
| 427 | In distribution | ||
| 7101 | 5 | In distribution | |
| SM40018 | 5 | In distribution | |
| 422 | 2 | In distribution | |
| 300 | 5 | In distribution | |
| 403W | 5 | In distribution | |
| 252 | 800 | In distribution | |
| B270 | 2,400 | In distribution | |
| SM41112 | 5 | In distribution | |
| 7103 | 5 | In distribution | |
| SM40748 | 5 | In distribution | |
| 211 | 200 | In distribution | |
| 426 | 5 | In distribution | |
| 401 | 5 | In distribution | |
| 7102 | 5 | In distribution | |
| 402 | 5 | In distribution | |
| B7101 | 100 | In distribution | |
| 450 | 5 | In distribution | |
| 311 | 5 | In distribution | |
| 420 | 5 | In distribution | |
| E7500 | In distribution | ||
| 7206 | 5 | In distribution | |
| 219 | 200 | In distribution | |
| 419 | 5 | In distribution | |
| 412 | 5 | In distribution | |
| B260 | 1,400 | In distribution | |
| 400W | 5 | Withdrawn | |
| B250W | 800 | Withdrawn | |
| NS1900-500 | 500 | Withdrawn | |
| 7205 | 5 | Withdrawn | |
| B7207 | 1,000 | Withdrawn | |
| 450BR | 5 | Withdrawn | |
| 1048-12-36XR | 3,600 | Withdrawn | |
| B250W-NL | 800 | Withdrawn | |
| LS800 | 800 | Withdrawn | |
| 204 | 200 | Withdrawn | |
| 407W | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMD-Ritmed | AMD Medicom Inc. | 248 |
| DeRoyal | Deroyal Industries, Inc. | 172 |
| Situate | Covidien LP | 60 |
| 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 |
| Fabco | First AID Bandage Co Inc | 27 |
Showing 12 of 82. All products under Gauze/Sponge, Internal, X-Ray Detectable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K810184 | 1981-02-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medical Action Industries, Inc. 306 | UDI-DI | 2018-11-27 | Class II | Under Investigation by firm | Potential compromise of product sterility due to breach of sterile barrier. | 13 cases (2,600 sponges) | 2019-02-08 |
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.