Vistec
X-Ray Detectable Sponges,Round Cotton-filled, X-Large
67manufacturers in China registered for this device type
22catalogue numbers in this listing
1recall
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 | Cardinal Health, United States |
|---|---|
| FDA product code | GDY |
| Device type | Gauze/Sponge, Internal, X-Ray Detectable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4450 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-30 |
| Record revised | 2025-12-31 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: This side up; |
| Packaging | Case of 2000, case of 1000, case of 480, case of 640, case of 1200, pack_or_inner_pack of 150 |
| Sizes | Length 4 to 8 in; width 3.5 to 4 in; outer diameter 1.125 to 2 in |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6493 | Outer Diameter 1.75 in | 500 | In distribution |
| 7463 | Length 8 in | 100 | In distribution |
| 7321 | Width 4 in | 10 | In distribution |
| VS4416 | Width 4 in | 1,800 | In distribution |
| 7319 | Width 4 in | 10 | In distribution |
| 6365 | Outer Diameter 1.125 in | 1,000 | In distribution |
| 28750 | Width 4 in | 5 | In distribution |
| 7318 | Length 8 in | 10 | In distribution |
| 2979 | Width 4 in | 100 | In distribution |
| 6653 | Outer Diameter 1.625 in | 1,000 | In distribution |
| 7466 | Length 8 in | 100 | In distribution |
| 7462 | Width 4 in | 100 | In distribution |
| VS4332 | Length 4 in | 980 | In distribution |
| 7320 | Length 4 in | 10 | Withdrawn |
| 7148 | Length 4 in | 100 | Withdrawn |
| 4334 | Length 4 in | 100 | Withdrawn |
| 1069 | Outer Diameter 2 in | 250 | Withdrawn |
| 6297 | Outer Diameter 1.3125 in | 1,000 | Withdrawn |
| 6591 | Outer Diameter 1.50 in | 1,000 | Withdrawn |
| 6449 | Outer Diameter 1.625 in | 1,000 | Withdrawn |
| 7317 | Width 4 in | 10 | Withdrawn |
| 7114 | Length 4 in | 100 | Withdrawn |
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
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 |
|---|---|---|---|---|---|---|---|
| Cardinal Health | UDI-DI | 2017-07-17 | Class II | Material/Component Contamination | Medtronic is voluntarily recalling two production lots of its Covidien Vistec” x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final pack | 33,280 | 2018-09-14 |
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.