Cardinal Health
Cardinal Health Lap Sponge 18 X 18 in. Prewashed X Ray Detectable With Plastic Rings Softpack
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 200, LLC, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-01-07 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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, manufacturing date |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Case of 40, case of 13, case of 2, case of 50, case of 10, pack of 64 |
| Sizes | Length 4 to 36 in; height 12 to 18 in; width 4 to 8 in |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 23250-402 | Length 18 in | 5 | In distribution |
| SBA31LSUCE | In distribution | ||
| 23250-419 | Length 36 in | 5 | In distribution |
| 23250-405 | Length 18 in | 5 | In distribution |
| SBA31LSUCA | In distribution | ||
| SBA31LSUCC | In distribution | ||
| SID11GGJEB | In distribution | ||
| SBA31LSUCD | In distribution | ||
| 17A1256C | In distribution | ||
| 23250-404 | Height 18 in | 5 | In distribution |
| 17A1256B | In distribution | ||
| C-NXR4432 | Width 4 in | 100 | In distribution |
| 14-0076 | In distribution | ||
| 23250-204 | Height 18 in | 200 | In distribution |
| 09-2637A | In distribution | ||
| 23250-211 | Length 12 in | 200 | In distribution |
| 23250-400A | Length 18 in | 5 | In distribution |
| SBA31LSUCB | In distribution | ||
| 23250-200 | Height 18 in | 200 | In distribution |
| 17A1256A | In distribution | ||
| C-NXR4816 | Length 4 in | 200 | In distribution |
| 23250-407 | Length 18 in | 5 | In distribution |
| 23250-411 | Height 12 in | 5 | In distribution |
| 23250-403 | Length 18 in | 5 | In distribution |
| 23250-409 | Length 12 in | 5 | In distribution |
| C-XR4416S | Length 4 in | 10 | Withdrawn |
| C-XR4812S | Width 8 in | 10 | 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
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.