Cardinal Health
X-Ray Detectable Sponges / 4 x 8in. (10.2 x 20.3cm) CAUTION: For External Use Only. 32-Ply Woven 100 percent Cotton with Wavy Barium Sulfate Band. Non Sterile. Single Use Only. Not Made…
X-Ray Detectable Sponges / 4 x 8in. (10.2 x 20.3cm) CAUTION: For External Use Only. 32-Ply Woven 100 percent Cotton with Wavy Barium Sulfate Band. Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.
266manufacturers in China registered for this device type
71catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (65), Jiangsu (64), Guangdong (29). 34 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 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Fomed Industries Inc | Qian Jiang | Hubei | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
Showing 12 of 266. All 266 manufacturers in China registered for Gauze / Sponge,Nonresorbable For External Use
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | NAB |
| Device type | Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4014 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-27 |
| 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 |
| Packaging | Case of 20, case of 10, case of 12, box of 25, case of 8, box of 50 |
| Sizes | Height 3 to 4 in; length 3 to 4 in |
| Distribution end date | 2030-12-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| C-SUS446S | Height 4 in | 2 | In distribution |
| C-CB3 | In distribution | ||
| 14-9194A | In distribution | ||
| 14-9192A | In distribution | ||
| C-NSG4412 | 200 | In distribution | |
| C-CB2 | In distribution | ||
| NI12-0025B | In distribution | ||
| C-CB6 | In distribution | ||
| C-CB2S | In distribution | ||
| SBA5DSPWAB | In distribution | ||
| BNS-SU666 | 100 | In distribution | |
| C-NWS224 | 200 | In distribution | |
| C-NWS334 | 200 | In distribution | |
| 12A7780 | In distribution | ||
| SID13DRMZB | In distribution | ||
| 12-0413 | In distribution | ||
| C-CB6S | In distribution | ||
| C-CB4S | In distribution | ||
| 14-9190A | In distribution | ||
| C-CB3S | In distribution | ||
| C-NWS444 | 200 | In distribution | |
| 12-0413A | In distribution | ||
| C-NSG448 | 200 | Withdrawn | |
| C-SG4812S | 2 | Withdrawn | |
| C-NSG228E | 200 | Withdrawn | |
| C-NWS444S | 2 | Withdrawn | |
| C-NXR4824 | 100 | Withdrawn | |
| C-NSG2212 | 200 | Withdrawn | |
| C-NSG3312E | 200 | Withdrawn | |
| C-SG4412ZE | 10 | Withdrawn | |
| C-NXR4424 | 100 | Withdrawn | |
| C-SG44082E | 2 | Withdrawn | |
| C-DRS4416S | Withdrawn | ||
| C-SUS66ZS | 10 | Withdrawn | |
| C-SG2208SE | 2 | Withdrawn | |
| C-NWS444ZS | 10 | Withdrawn | |
| C-SG4412ZS | 10 | Withdrawn | |
| C-SG4416S | 10 | Withdrawn | |
| C-SG44082S | 50 | Withdrawn | |
| C-NXR4416 | 100 | Withdrawn | |
| C-NWS224S | 2 | Withdrawn | |
| C-SG44121S | Length 4 in | Withdrawn | |
| C-NWS334S | Height 3 in | 2 | Withdrawn |
| C-SG2208S | 2 | Withdrawn | |
| C-NSG3312 | 200 | Withdrawn | |
| C-NXR4832 | 100 | Withdrawn | |
| C-NSG4412E | 200 | Withdrawn | |
| C-NSG448E | 200 | Withdrawn | |
| BNS-3432 | 100 | Withdrawn | |
| C-SG34S | 2 | Withdrawn | |
| C-NSG34 | 100 | Withdrawn | |
| C-SG44122S | 2 | Withdrawn | |
| C-SUS665S | 5 | Withdrawn | |
| C-NWS223 | 200 | Withdrawn | |
| C-NWSD443 | 200 | Withdrawn | |
| C-NXR4412 | 200 | Withdrawn | |
| C-SG44S | 2 | Withdrawn | |
| C-NSG33 | 100 | Withdrawn | |
| C-SUS4412S | 2 | Withdrawn | |
| C-NWDS446S | 2 | Withdrawn | |
| C-SG44122E | 25 | Withdrawn | |
| C-SG448ZS | 10 | Withdrawn | |
| C-NWS443 | 200 | Withdrawn | |
| C-NSG4416 | 200 | Withdrawn | |
| C-NSG228 | 200 | Withdrawn | |
| C-NSG2212E | 200 | Withdrawn | |
| C-NXR4812 | 100 | Withdrawn | |
| C-NWS446S | 2 | Withdrawn | |
| C-SUS662S | 2 | Withdrawn | |
| C-NWDS226S | 2 | Withdrawn | |
| C-NSG4812 | 200 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Techno-Aide | Techno-Aide, Inc. | 295 |
| DeRoyal | Deroyal Industries, Inc. | 232 |
| Medline | Medline Industries, Inc. | 194 |
| Avaline Medical NJ LLC | Avaline Medical NJ Limited Liability Company | 132 |
| McKesson | Mckesson Medical-Surgical Inc. | 112 |
| Dukal | Dukal LLC | 112 |
| Henry Schein | Henry Schein, Inc. | 110 |
| MediChoice | Owens & Minor Distribution, Inc. | 73 |
| Medical Action Industries | Medical Action Industries, Inc. | 56 |
| A Plus | A Plus International, Inc | 55 |
| Curity | Cardinal Health | 53 |
| Dermacea | Cardinal Health | 53 |
Showing 12 of 308. All products under Gauze / Sponge,Nonresorbable For External Use
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-12-27 | Class II | Under Investigation by firm | Curity All Purpose Sponges were not sterilized and distributed | 10,400 units (13 cases, 800 units/case) | 2020-06-29 |
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.