Injection Needle
angled, luer-lock 0.8 mm, wl 10.5 cm, total length 13 cm
7manufacturers in China registered for this device type
5catalogue numbers in this listing
1recall
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 | Spiggle & Theis Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | GDM |
| Device type | Needle, Aspiration And Injection, Reusable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-122-08 | In distribution | |
| 50-345-23 | In distribution | |
| 50-353-23 | In distribution | |
| 40-553-01 | In distribution | |
| 40-553-02 | In distribution |
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
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Spiggle & Theis Medizintechnik Gmbh | UDI-DI | 2025-06-27 | Class II | Under Investigation by firm | Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction. |
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.