Monoject
Basic Bone Marrow Biopsy and Aspiration Tray with Safety Components,16 G I-Type Sternal-Iliac Needle and 11 G Snarecoil Bone Marrow Biopsy / Aspiration Needle
37manufacturers in China registered for this device type
33catalogue 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 | Cardinal Health, 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, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-30 |
| Record revised | 2025-12-31 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: ; |
| Packaging | Case of 10, pack_or_inner_pack of 100, case of 1000, case of 2800, case of 3200, pallet of 1800 |
| Sizes | Length 0.75 to 4 in; needle gauge 18 G |
| Distribution end date | 2026-01-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SC4511 | Needle Gauge,16 (I-Type) and 11 (Bone Marrow Biopsy),Gauge; | In distribution | |
| 8881247111 | Needle Gauge,11,Gauge; | In distribution | |
| 8881247087 | Needle Gauge,8,Gauge; | In distribution | |
| 8881204021 | Needle Gauge,20,Gauge; | 100 | In distribution |
| SCE3411 | Needle Gauge,11,Gauge; | In distribution | |
| 8881305117 | Length 1.50 in | 100 | In distribution |
| SCE4511 | Needle Gauge,16 (I-Type) and 11 (Bone Marrow Biopsy),Gauge; | In distribution | |
| SC4508 | Needle Gauge,16 (I-Type) and 8 (Bone Marrow Biopsy),Gauge; | In distribution | |
| 8881305018 | Needle Gauge,20,Gauge; | 100 | In distribution |
| SC3411 | Needle Gauge,11,Gauge; | In distribution | |
| SC3353 | Needle Gauge,13,Gauge; | In distribution | |
| 8881202397 | Needle Gauge,23,Gauge; | 25 | Withdrawn |
| 8881847993 | Withdrawn | ||
| 8881245164 | Needle Gauge,16,Gauge;Length,3/16 to 1-7/8,Inch; | Withdrawn | |
| 8881247137 | Length 3.50 in | Withdrawn | |
| 8881847167 | Needle Gauge,16,Gauge; | Withdrawn | |
| 8881202322 | Needle Gauge,16,Gauge; | 25 | Withdrawn |
| 8881200003 | Needle Gauge,16,Gauge; | 100 | Withdrawn |
| 8881847035 | Needle Gauge,16,Gauge; | Withdrawn | |
| 8881305109 | Needle Gauge,18,Gauge; | 25 | Withdrawn |
| 8881202389 | Needle Gauge,22,Gauge; | 25 | Withdrawn |
| 8881204005 | Needle Gauge,20,Gauge; | 500 | Withdrawn |
| 8881847084 | Needle Gauge,8,Gauge; | Withdrawn | |
| 8881247129 | Needle Gauge,13,Gauge; | Withdrawn | |
| 320872 | Length 1.625 in | 2,000 | Withdrawn |
| 8881202082 | Length 1 in | 100 | Withdrawn |
| 8881202371 | Needle Gauge,21,Gauge; | 25 | Withdrawn |
| 8881202314 | Length 1.50 in | 25 | Withdrawn |
| 8881847118 | Needle Gauge,11,Gauge; | Withdrawn | |
| 8881847019 | Needle Gauge,16,Gauge; | Withdrawn | |
| 8881202348 | Needle Gauge,18,Gauge; | 25 | Withdrawn |
| 11811022 | Needle Gauge 18 G | Withdrawn | |
| 8881202330 | Needle Gauge,17,Gauge; | 25 | 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 |
| 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
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.