Sorbalux ABD PAD ST 3×5 400/CS
Catalogue number 15700004, listed by Hartmann USA Inc., United States, under Gauze / Sponge,Nonresorbable For External Use. 266 manufacturers in China are registered for this product code.
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 | Hartmann USA Inc., United States |
|---|---|
| FDA product code | NAB |
| Device type | Gauze / Sponge,Nonresorbable For External Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4014 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-22 |
| Record revised | 2024-11-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 25, pack of 16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15700004 | In distribution |
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
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2012-05-14 | Class II | Material/Component Contamination | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products | Lot 102147399 – 421 Cases; Lot 102250396 – 360 Cases; 200105 | 2014-10-06 |
| 2012-05-14 | Class II | Material/Component Contamination | Micro holes were detected in the laminate of the sterile barrier system of sterilized Hartmann Econolux and Hartmann Sterilux gauze products | Lot 101546391 – 200 cs; Lot 101646398 – 200 cs; 101747392 – | 2014-10-06 |
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.