Stradis
Sterile Separates 2X2 Sterile Gauze Pack Stradis
266manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Stradis Healthcare, 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 | 2017-02-01 |
| Record revised | 2023-02-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 30 |
| Sizes | Area/surface area 4 to 6 Square inch; length 4 in |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 816-656N | Area/Surface Area 6 Square inch | In distribution |
| 816-454N R1 | Area/Surface Area 4 Square inch | In distribution |
| 816-454N | Area/Surface Area 4 Square inch | In distribution |
| 840-404-I | Area/Surface Area 4 Square inch | Withdrawn |
| 816-656N | Area/Surface Area 6 Square inch | Withdrawn |
| 525-111 | Length 4 in | Withdrawn |
| 816-454N | Area/Surface Area 4 Square inch | Withdrawn |
| 525-112 | 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 |
| Medical Action Industries | Medical Action Industries, Inc. | 56 |
| A Plus | A Plus International, Inc | 55 |
| Curity | Cardinal Health | 53 |
Showing 12 of 308. All products under Gauze / Sponge,Nonresorbable For External Use
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.