CytoCut
10 CS - Disposable Chiba Needle 20G X 200 MM FOR Aspirated Cyto-Histological Biopsy
37manufacturers in China registered for this device type
28catalogue numbers in this listing
1recall
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 | M.D.L. S.R.L., Italy |
|---|---|
| FDA product code | GAA |
| Device type | Needle, Aspiration And Injection, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-14 |
| Record revised | 2021-05-27 (version 7) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Sizes | Needle gauge 18 to 22 G; length 100 to 250 mm |
| Distribution end date | 2021-05-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PB2015 | Needle Gauge 20 G | In distribution |
| PB2225 | Length 250 mm | In distribution |
| PB2110 | Needle Gauge 21 G | In distribution |
| PB2115 | Needle Gauge 21 G | In distribution |
| PB1825 | Length 250 mm | In distribution |
| PB1820 | Needle Gauge 18 G | In distribution |
| PB2010 | Needle Gauge 20 G | In distribution |
| PB2210 | In distribution | |
| PB2020 | Length 200 mm | In distribution |
| PB2120 | Needle Gauge 21 G | In distribution |
| PB2215 | Length 150 mm | In distribution |
| PB1815 | Length 150 mm | In distribution |
| PB1810 | Needle Gauge 18 G | In distribution |
| PB2220 | Needle Gauge 22 G | In distribution |
| PB2210 | Withdrawn | |
| PB2225 | Length 250 mm | Withdrawn |
| PB2010 | Needle Gauge 20 G | Withdrawn |
| PB2020 | Length 200 mm | Withdrawn |
| PB2220 | Needle Gauge 22 G | Withdrawn |
| PB2215 | Length 150 mm | Withdrawn |
| PB2015 | Needle Gauge 20 G | Withdrawn |
| PB2110 | Needle Gauge 21 G | Withdrawn |
| PB1825 | Length 250 mm | Withdrawn |
| PB1815 | Length 150 mm | Withdrawn |
| PB2115 | Needle Gauge 21 G | Withdrawn |
| PB1820 | Needle Gauge 18 G | Withdrawn |
| PB2120 | Needle Gauge 21 G | Withdrawn |
| PB1810 | Needle Gauge 18 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 298 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 148 |
| Zavation | Zavation | 121 |
| Whiterose Micro Cannula | UC Medical | 38 |
| Monoject | Cardinal Health | 33 |
| MagniCore | Cook Incorporated | 29 |
| Breast localisation needle | Möller Medical GmbH | 29 |
| 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
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 |
|---|---|---|---|---|---|
| 2021-08-05 | Class II | Other | Sterility assurance may be compromised. | 2750 devices | 2026-05-04 |
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.