Elastomull®
Elastomull Sterile 7.6CMX3.75M 12
280manufacturers in China registered for this device type
4catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (85), Zhejiang (75), Guangdong (29). 38 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 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Nanjing 3H Medical Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 25 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
Showing 12 of 280. All 280 manufacturers in China registered for Bandage, Elastic
Record
| Listed by | BSN Medical, Inc., United States |
|---|---|
| FDA product code | FQM |
| Device type | Bandage, Elastic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-07-28 |
| Record revised | 2022-12-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Pack of 8 |
| Sizes | Width 2.5 to 10 cm; length 375 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 020760-01 | Width 5 cm | 12 | In distribution |
| 020700-01 | Width 7.6 cm | 12 | In distribution |
| 020710-01 | Width 10 cm | 12 | In distribution |
| 020750-01 | Width 2.5 cm | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 194 |
| MT Spandage | Medi-Tech, Inc. | 107 |
| Tronex International, Inc. | Tronex International, Inc. | 79 |
| Bioseal Inc. | Bioseal | 57 |
| Medline | Medline Industries, Inc. | 56 |
| 3M™ Coban™ | 3M Company | 52 |
| Sensi-Wrap, Self Adherent | Dynarex Corp. | 49 |
| Cardinal Health | Cardinal Health 200, LLC | 49 |
| Bandage, Elastic | Tetra Medical Supply Corp. | 48 |
| PremierPro | Prestige Ameritech | 48 |
| Co-Ease | Hemasource | 45 |
| CotZee | Hemasource | 44 |
Showing 12 of 345. All products under Bandage, Elastic
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 |
|---|---|---|---|---|---|
| 2022-02-01 | Class II | Under Investigation by firm | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. | 1,677 | 2023-08-09 |
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.