Hensler Bone Press
The Bone Press is a medical device and has been developed to maximize the collection and separation of autologous bone from blood and irrigants for bone fusion applications. No additional…
The Bone Press is a medical device and has been developed to maximize the collection and separation of autologous bone from blood and irrigants for bone fusion applications. No additional accessories are provided with this device outside of what is in the kit. The Hensler Bone Press (HBP) is intended for sterile, single-use with a surgical suction line to collect autologous bone or tissue particles that are utilized in bone fusion. The device may be used by specially qualified health care professionals including surgeons, physician assistants, first assists and certified scrub technicians.
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (5), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Zhejiang Anji Huabu Industrial Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 32 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
Showing 12 of 19. All 19 manufacturers in China registered for Trap, Sterile Specimen
Record
| Listed by | Hensler Surgical |
|---|---|
| FDA product code | BYZ |
| Device type | Trap, Sterile Specimen |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Premarket notification | Exempt |
| Record published | 2019-11-01 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep Dry and away from sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HBP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Argyle | Cardinal Health | 11 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 4 |
| Medichoice | Owens & Minor Distribution, Inc. | 4 |
| Medline | Medline Industries, Inc. | 4 |
| Environ-mate | M D Technologies, Inc. | 3 |
| Disposable BoneBac Press | Thompson MIS | 3 |
| Cardinal Health | Cardinal Health 200, LLC | 3 |
| Allegiance | Cardinal Health 200, LLC | 2 |
| Medline ReNewal | Medline Industries, Inc. | 2 |
| Andorate® | Smartdata Suzhou Co., Ltd. | 2 |
| Customed | Customed, Inc. | 2 |
| Baleen Polyp Trap | N.M. Beale Co., Inc. | 1 |
Showing 12 of 30. All products under Trap, Sterile Specimen
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.