3m™ Scotchcast™
3M™ Scotchcast™ Wet or Dry Cast Padding, WDP3, 3 IN X 4 YDS, 20 Roll/Bag, 4 Bag/Case
81manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Zhejiang (26), Jiangsu (19), Shanghai (10). 13 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 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Kingstar Medical (Xianning) Co., Ltd. | Xianning | Hubei | Contract manufacturer | 17 |
| Suzhou Avon Textile Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 12 |
| Anhui Ivymed Medical Products Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 10 |
| Suzhou Dukangning Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 81. All 81 manufacturers in China registered for Bandage, Cast
Record
| Listed by | 3M Company, United States |
|---|---|
| FDA product code | ITG |
| Device type | Bandage, Cast |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3025 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2024-02-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| WDP6 | 20 | In distribution | |
| WDP3 | 20 | In distribution | |
| WDP2 | 20 | In distribution | |
| WDP4 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Scotchcast™ | Solventum US LLC | 58 |
| Bandage, Cast | Tetra Medical Supply Corp. | 55 |
| Tex-Care Medical | Flynt Amtex, Inc. | 45 |
| DeRoyal | Deroyal Industries, Inc. | 35 |
| McKesson | Mckesson Medical-Surgical Inc. | 34 |
| PremierPro | Prestige Ameritech | 31 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 25 |
| TCC-EZ® | Acell, Inc. | 24 |
| Woodcast | Dassiet Oy | 15 |
| Curity | Cardinal Health | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 13 |
| Senolo | Jiangsu Senolo Medical Technology Co., Ltd. | 13 |
Showing 12 of 66. All products under Bandage, Cast
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K791094 | 1979-07-24 |
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 |
|---|---|---|---|---|---|
| 2013-08-05 | Class II | Nonconforming Material/Component | 3M is conducting a voluntary product recall of selected lots of 3M” Scotchcast” Wet or Dry Cast Padding. Upon investigation of a health care provider feedback, and confirmed with internal testing, it was found that the cast padding materi | 1207 cases (4 puches per case, 20 rolls per pouch) | 2014-06-16 |
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.