Pilling
Sponge Cylindrical Sterile 3/8" X1 1/2" Center-Strung 100/ BOX
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 | Teleflex Medical 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K913302 |
| Record published | 2018-09-15 |
| Record revised | 2020-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 20, box of 40, box of 100, box of 200, box of 5 |
| Sizes | Width 0.75 to 4 in; length 2.75 to 5 in; width 58 mm; length 86 mm; depth 0.5 to 0.878 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN004245 | Depth 0.5 in | 5 | In distribution |
| IPN004259 | Width 58 mm | 10 | In distribution |
| IPN004272 | Width 58 mm | 5 | In distribution |
| IPN004244 | Width 2.25 in | 10 | In distribution |
| IPN004270 | Length 86 mm | 5 | In distribution |
| IPN004257 | Depth 0.5 in | 5 | In distribution |
| IPN004266 | Length 86 mm | 5 | In distribution |
| IPN004246 | Width 1 in | 5 | In distribution |
| IPN004261 | Length 4.25 in | 10 | In distribution |
| IPN004265 | Length 86 mm | 5 | In distribution |
| IPN004275 | Width 58 mm | 5 | In distribution |
| IPN004267 | Width 58 mm | 5 | In distribution |
| IPN004268 | Length 86 mm | 5 | In distribution |
| IPN004264 | Length 86 mm | 10 | In distribution |
| IPN004252 | Width 1 in | 5 | In distribution |
| IPN004253 | Width 2.5 in | 10 | In distribution |
| IPN004250 | Length 2.75 in | 5 | In distribution |
| IPN004254 | Width 2.5 in | 10 | In distribution |
| IPN004256 | Depth 0.5 in | 5 | In distribution |
| IPN004280 | In distribution | ||
| IPN004247 | Length 5 in | 100 | In distribution |
| IPN004243 | Length 4 in | 5 | In distribution |
| IPN004258 | Depth 0.5 in | 5 | In distribution |
| IPN004255 | Length 4 in | 10 | In distribution |
| IPN004269 | Length 86 mm | 5 | In distribution |
| IPN004251 | Width 1 in | 5 | In distribution |
| IPN004271 | Length 86 mm | 5 | In distribution |
| IPN004248 | Width 2.25 in | 5 | In distribution |
| IPN004274 | Length 86 mm | 5 | In distribution |
| IPN004249 | Width 4 in | 5 | In distribution |
| IPN004260 | Width 58 mm | 10 | 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 |
| Fabco | First AID Bandage Co Inc | 27 |
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.