AndoFlex UBZ
Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features…
Two-Layer Kit Layer 1 is a soft foam roll impregnated with zinc that soothes and calms skin. Layer 2 is a non-latex short stretch compression bandage that sticks to itself and features EasyTear technology, eliminating the need for scissors. AndoFlex® TLC Zinc provides a two-step level of comfort unlike any other 2-layer Unna boot on the market. Zinc NL TAN 4
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 | Andover Healthcare, Inc., United States |
|---|---|
| FDA product code | FQM |
| Device type | Bandage, Elastic |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-04-05 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 77 °F |
| Packaging | Case of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4″W/IN TN 3 | In distribution | |
| Zinc NL TAN 4 | 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
7 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 |
|---|---|---|---|---|---|
| 2024-04-02 | Class II | Process control | A packaging seal gap could impact the sterility of the product. | 108 cases (1,944 individual product packages) | |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 1798 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 330 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 1759 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 269 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 1050 Cases | 2020-09-09 |
| 2019-06-19 | Class II | Packaging | Incomplete packaging seal of sterile product | 8500 Cases | 2020-09-09 |
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.