Zavation
ZVplasty Cement Mixer and Injection Gun Kit
37manufacturers in China registered for this device type
121catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Jiangsu (7), Shanghai (6). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | Jiading | Shanghai | Contract manufacturer | 11 |
| Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Taihu | Anhui | Contract manufacturer | 8 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
Showing 12 of 37. All 37 manufacturers in China registered for Needle, Aspiration And Injection, Disposable
Record
| Listed by | Zavation, United States |
|---|---|
| FDA product code | GAA |
| Device type | Needle, Aspiration And Injection, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K141419 |
| Record published | 2019-02-19 |
| Record revised | 2024-04-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-03-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VCF-1020-2-BDX | In distribution | |
| VCF-1015-2G-LV-E-BDX | In distribution | |
| VCF-1006 | In distribution | |
| VCF-1020-2-E-BXC | In distribution | |
| VCF-1010-2-NC | In distribution | |
| VCF-1015-2G-LV-BXX | In distribution | |
| VCF-1020-2A-BDX | In distribution | |
| VCF-1010-2A-BXX | In distribution | |
| VCF-1010-2G-E-BXX | In distribution | |
| VCF-1010-2-XXC | In distribution | |
| VCF-1020-1G-E | In distribution | |
| VCF-1010-1-LV-E | In distribution | |
| VCF-1015-1-LV-E | In distribution | |
| VCF-1020-2-LV-BDX | In distribution | |
| VCF-1010 | In distribution | |
| VCF-1010-1G | In distribution | |
| VCF-1020-2A-LV-BXX | In distribution | |
| VCF-1010-2-LV-BDC | In distribution | |
| VCF-1015-1A | In distribution | |
| VCF-CCUR-11 | In distribution | |
| VCF-1015-2-LV-XDX | In distribution | |
| VCF-1024 | In distribution | |
| VCF-1010-2G-LV-E-BXX | In distribution | |
| VCF-1015-2A-XDC | In distribution | |
| VCF-1010-2-E-BXC | In distribution | |
| VCF-1010-2-E-BXX | In distribution | |
| VCF-1015-2-XXC | In distribution | |
| VCF-1020-2A-BXX | In distribution | |
| VCF-1015-1G-E | In distribution | |
| VCF-1015-2-E-BDC | In distribution | |
| VCF-1000 | In distribution | |
| VCF-1015-2A-XXC | In distribution | |
| VCF-1173 | In distribution | |
| VCF-1015-2-LV | In distribution | |
| VCF-1015-2-LV-E-XDC | In distribution | |
| VCF-1015-2G-LV | In distribution | |
| VCF-1020-2A-XXC | In distribution | |
| VCF-1000-LV | In distribution | |
| VCF-1015-2G-E-XDX | In distribution | |
| VCF-1015-2-LV-BXX | In distribution | |
| VCF-1010-2G-BXX | In distribution | |
| VCF-1015-2G-LV-E-XDX | In distribution | |
| VCF-1010-2A-LV-BXC | In distribution | |
| VCF-1020-2G-E-BDX | In distribution | |
| VCF-1060 | In distribution | |
| VCF-1010-1A | In distribution | |
| VCF-1020-2-BXX | In distribution | |
| VCF-1010-2-LV-E-BXX | In distribution | |
| VCF-1010-2G-BDX | In distribution | |
| VCF-1000-15 | In distribution | |
| VCF-1010-2-E-BDX | In distribution | |
| VCF-1020-2-E-XXC | In distribution | |
| VCF-1015-2A-LV-BXX | In distribution | |
| VCF-1052 | In distribution | |
| VCF-1020-2G-XDX | In distribution | |
| VCF-1015-2G-E-BDX | In distribution | |
| VCF-1015-1-LV | In distribution | |
| VCF-1020-2A-XDC | In distribution | |
| VCF-1010-2A-BDX | In distribution | |
| VCF-1010-2A-LV-BDC | In distribution | |
| VCF-1020-2-E-XDC | In distribution | |
| VCF-1020-2G-LV-E-BDX | In distribution | |
| VCF-1010-1G-LVE | In distribution | |
| VCF-1010-2-XDX | In distribution | |
| VCF-1010-2A-BDC | In distribution | |
| VCF-1010-2A-LV-BDX | In distribution | |
| VCF-1015-2-BDX | In distribution | |
| VCF-1010-2G-E-BDX | In distribution | |
| VCF-1015-2-E-XXC | In distribution | |
| VCF-1010-2G-LV-BDX | In distribution | |
| VCF-1020-1-LV-E | In distribution | |
| VCF-1015-2-LV-BDX | In distribution | |
| VCF-1020-2-LV-E-BXC | In distribution | |
| VCF-1020-2A-LV-XDX | In distribution | |
| VCF-1020-2G-E-XDX | In distribution | |
| VCF-1010-2-LV-E-BDX | In distribution | |
| VCF-1020-2G-LV-E-XDX | In distribution | |
| VCF-1020-2G-LV-BXX | In distribution | |
| VCF-1010-2-LV-BDX | In distribution | |
| VCF-1010-2-LV-E-BXC | In distribution | |
| VCF-1020-2A-LV-BDX | In distribution | |
| VCF-1010-2-LV-BXX | In distribution | |
| VCF-1020-1 | In distribution | |
| VCF-1020-2G-BXX | In distribution | |
| VCF-1020-2A-LV | In distribution | |
| VCF-1010-2A-LV-BXX | In distribution | |
| VCF-1016 | In distribution | |
| VCF-1010-2-E-BDC | In distribution | |
| VCF-1010-2 | In distribution | |
| VCF-1015-2G-BXX | In distribution | |
| VCF-OSFL | In distribution | |
| VCF-1010-2G-LV-E-BDX | In distribution | |
| VCF-1015-2A-BDX | In distribution | |
| VCF-1015-2-BXX | In distribution | |
| VCF-1015-1 | In distribution | |
| VCF-1015-2-XDC | In distribution | |
| VCF-1015-2A-BXX | In distribution | |
| VCF-1010-2-LV-BXC | In distribution | |
| VCF-1022 | In distribution | |
| VCF-1080-S4 | In distribution | |
| VCF-1010-2-LV-E-BDC | In distribution | |
| VCF-1015-2-LV-E-BXC | In distribution | |
| VCF-1010-2-BDC | In distribution | |
| VCF-1010-2G-LV-BXX | In distribution | |
| VCF-1015-2-LV-E-BDC | In distribution | |
| VCF-1020-2A | In distribution | |
| VCF-1015-2A-LV-XDX | In distribution | |
| VCF-1015-2-E-XDC | In distribution | |
| VCF-1015-2G-XDX | In distribution | |
| VCF-1020-2-E-BDC | In distribution | |
| VCF-1015-2A-LV-BDX | In distribution | |
| VCF-1020-1G-LV | In distribution | |
| VCF-1000-11-20 | In distribution | |
| VCF-1015-2A | In distribution | |
| VCF-1015-2-LV-E-XXC | In distribution | |
| VCF-1020-2-LV-BXX | In distribution | |
| VCF-1020-2-LV-E-BDC | In distribution | |
| VCF-1010-2A-BXC | In distribution | |
| VCF-1015-2-E-BXC | In distribution | |
| VCF-1015-1-E | Withdrawn | |
| VCF-1020 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 298 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 148 |
| Whiterose Micro Cannula | UC Medical | 38 |
| Monoject | Cardinal Health | 33 |
| MagniCore | Cook Incorporated | 29 |
| Breast localisation needle | Möller Medical GmbH | 29 |
| CytoCut | M.D.L. S.R.L. | 28 |
| Chiba Needle Marked | Remington Medical, Inc. | 26 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 24 |
| Breast Localization Needles | Argon Medical Devices, Inc. | 23 |
| Fine Needle Aspiration | Mermaid Medical A/S | 22 |
| Coaxial Interventional Needle | Itp Innovative Tomography Products GmbH | 20 |
Showing 12 of 183. All products under Needle, Aspiration And Injection, Disposable
Recalls Naming This Product
36 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 56 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 38 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 335 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 88 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 14 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 11 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 72 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 1 unit | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 98 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 113 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 15 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 72 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 162 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 34 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 98 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 27 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 11 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 113 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 15 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 22 units | 2023-03-20 |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 | |
| Zavation | 510(k) number | 2021-03-25 | Class II | Vendor change control | Products distributed as sterile may not have been adequately sterilized | 2023-03-20 |
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.