Medical Action Industries
Gauze: Fluff 30x18 1 Ply Mesh 300/Cs
266manufacturers in China registered for this device type
56catalogue numbers in this listing
1510(k) clearance
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 | Medical Action Industries, Inc., United States |
|---|---|
| FDA product code | NAB |
| Device type | Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4014 |
| Premarket notification | Exempt |
| Record published | 2021-04-12 |
| Record revised | 2023-04-04 (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: store at room temperature |
| Packaging | Pack of 20, pack of 50, pack of 25, pack of 100, pack of 10, pack of 12 |
| Distribution end date | 2023-11-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 12-818-04 | 3 | In distribution | |
| 33424 | 200 | In distribution | |
| 12-728-09 | In distribution | ||
| 1044-8-4 | 200 | In distribution | |
| 22424 | 200 | In distribution | |
| 1048-12-2 | 200 | In distribution | |
| 12-918-02 | 2 | In distribution | |
| 12-918-01 | 2 | In distribution | |
| 44258A-TEST | In distribution | ||
| 2208CP | 200 | In distribution | |
| 12-927-10 | 10 | In distribution | |
| GF-403 | 3 | In distribution | |
| 12-818-66 | 4 | In distribution | |
| 12-927-05 | 5 | In distribution | |
| 1044-12-2 | 200 | In distribution | |
| GF-411 | In distribution | ||
| 1140-45 | 700 | In distribution | |
| 24230 | 2 | In distribution | |
| 52911 | In distribution | ||
| 12-918-59 | In distribution | ||
| 12-928-65 | In distribution | ||
| GF-4010 | 10 | In distribution | |
| 12-902-44 | 5 | In distribution | |
| 44422 | 200 | In distribution | |
| 1044-16-2 | 200 | In distribution | |
| 1140-28 | 80 | In distribution | |
| 1033-8-4 | 200 | In distribution | |
| 12-918-15 | In distribution | ||
| 12-818-40 | In distribution | ||
| 1033-12-4 | 200 | In distribution | |
| 12-918-30 | 2 | In distribution | |
| 12-928-61 | In distribution | ||
| 12-918-28 | In distribution | ||
| 12-918-20 | 4 | In distribution | |
| 1022-12-8 | 200 | In distribution | |
| 1140-59 | 240 | In distribution | |
| 481210 | 10 | In distribution | |
| 12-918-72 | In distribution | ||
| 44212 | 2 | In distribution | |
| 41212 | 2 | In distribution | |
| 44258A | In distribution | ||
| 1022-8-5 | 200 | In distribution | |
| 12-818-41 | In distribution | ||
| 12-818-45 | In distribution | ||
| 52911 | Withdrawn | ||
| 52909 | Withdrawn | ||
| 68170 | Withdrawn | ||
| 12-915-91 | 5 | Withdrawn | |
| 12-928-96 | Withdrawn | ||
| 12-928-70 | 960 | Withdrawn | |
| 46206 | 2 | Withdrawn | |
| 12-918-71 | Withdrawn | ||
| 52913 | Withdrawn | ||
| 52910 | Withdrawn | ||
| 48160 | 10 | Withdrawn | |
| 2334 | 600 | 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 |
| Cardinal Health | Cardinal Health 200, LLC | 71 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K923846 | 1992-09-11 |
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.