Aspiration Needle
This model includes one of sheath section and six of needle sections. The sheath section is reusable and requires autoclave sterilization prior to use. The needle section is single-use and…
This model includes one of sheath section and six of needle sections. The sheath section is reusable and requires autoclave sterilization prior to use. The needle section is single-use and packaged as sterile. Please refer to the instruction manual for details.
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Anhui JM Healthcare Products Co., Ltd. | Shouxian | Anhui | Manufacturer | 25 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Wenzhou Aochang Misawa Medical Tech. Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 4 |
| Zhenjiang Dingfeng Needle Manufacturing Technology Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 1 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | GDM |
| Device type | Needle, Aspiration And Injection, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-21 |
| Record revised | 2022-08-19 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 6 |
| Distribution end date | 2022-08-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NA-2C-1 | Withdrawn | |
| NA-1C-1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medco Manufacturing | Medco Manufacturing LLC | 170 |
| Millennium | Avalign Technologies, Inc. | 53 |
| Instrumentarium | Société Chirurgicale Instrumentarium Inc | 39 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 35 |
| Pilling | Teleflex Medical LLC | 31 |
| Breast Localization Needles | Argon Medical Devices, Inc. | 27 |
| Tri-Port Cannula | Möller Medical GmbH | 20 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 19 |
| Multi-Hole Cannula | Möller Medical GmbH | 18 |
| MicroFrance® | Integra Microfrance SAS | 18 |
| Rapid Extraction Cannula | Möller Medical GmbH | 16 |
| Candy Cane Cannula | Möller Medical GmbH | 16 |
Showing 12 of 92. All products under Needle, Aspiration And Injection, Reusable
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.