Anatomical Shoulder™
Catalogue number 01.04237.720, listed by Zimmer, Inc., United States, under Tape, Orthopedic. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (3), Shaanxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shaanxi Ansen Medical Technology Development Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Yancheng Trancom First AID Supplies Industrial Co., Ltd. | Yangcheng | Jiangsu | Contract manufacturer | 25 |
| Changzhou DL Medical & Health Equipment Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | HXT |
| Device type | Tape, Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-30 |
| Record revised | 2021-11-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.04237.720 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pannus Retention System | Stetrix Inc. | 3 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 3 |
| V. Mueller | Steris Corporation | 1 |
| Meijer | Meijer, Inc. | 1 |
| Jannus Pannus Retractor | Stetrix Inc. | 1 |
| Lyftee | Stetrix Inc. | 1 |
| Panni Retractor System | Stetrix Inc. | 1 |
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.