Cylindrical Sponge
Cylindrical Sponges-Strung 3/8" x 3/4"
107manufacturers in China registered for this device type
3catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (23), Zhejiang (20), Anhui (14). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| 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 Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Jiujiang Huada Medical Dressing Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 18 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Kingstar Industries (Wuhan) Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 10 |
| Winner Medical (Jiayu) Co., Ltd. | Jiayu | Hubei | Contract manufacturer | 7 |
| Dalian Wenjing Wooden Industry Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 6 |
Showing 12 of 107. All 107 manufacturers in China registered for Cotton, Roll
Record
| Listed by | American Surgical Company, LLC, United States |
|---|---|
| FDA product code | EFN |
| Device type | Cotton, Roll |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6050 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K872810 |
| Record published | 2017-08-11 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70-05 | 50 | In distribution | |
| 70-02 | 50 | In distribution | |
| 70-01 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 18 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 15 |
| Henry Schein | Henry Schein, Inc. | 13 |
| Cardinal Health | Cardinal Health 200, LLC | 11 |
| Supplies | American Orthodontics | 10 |
| Safe Dent | Bgss Company Inc | 4 |
| JMU | JMU Dental, Inc | 4 |
| Burkhart Non-Woven Sponges | Crosstex International | 3 |
| Cotton Roll Holders | American Orthodontics | 3 |
| Monoart | Euronda SPA | 3 |
| Crosstex International | Crosstex International | 3 |
| National Hospital Packaging | Surgi-Pak, Inc. | 3 |
Showing 12 of 47. All products under Cotton, Roll
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| American Surgical Company, LLC | 510(k) number | 2016-03-31 | Class II | Packaging process control | Product packaging defective compromising sterility | 11 boxes | 2016-10-21 |
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.