Stimuplex®
Stimuplex® Ultra 22 Ga. x 3-1/8 in. (80 mm) Insulated Echogenic Needle with 30° Bevel and Extension Set (STIMAU2280/30)
9manufacturers in China registered for this device type
24catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (5), Shanghai (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Ningbo Linstant Polymer Materials Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 1 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Shanghai SA Medical & Plastic Instruments Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | B. Braun Medical Inc., United States |
|---|---|
| FDA product code | BSP |
| Device type | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5150 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2020-09-21 |
| Record revised | 2021-03-12 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 18 |
| Distribution end date | 2026-06-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4892712NR-02 | Gauge (cannula) : 20 | 10 | In distribution |
| 333676 | Gauge (cannula) : 22 | 25 | In distribution |
| 4892708NR-02 | Gauge (cannula) : 22 | 10 | In distribution |
| 333670 | Gauge (cannula) : 25 | 25 | In distribution |
| 4892705-01 | Gauge (cannula) : 22 | 10 | In distribution |
| 333672 | Gauge (cannula) : 23 | 25 | In distribution |
| 4892715-01 | Gauge (cannula) : 20 | 10 | In distribution |
| 4892710-02 | Gauge (cannula) : 20 | 10 | In distribution |
| 4892715-02 | Gauge (cannula) : 20 | 10 | In distribution |
| 4892715NR-02 | Gauge (cannula) : 20 | 10 | In distribution |
| 333689 | Gauge (cannula) : 22 | 25 | In distribution |
| 4892705NR-02 | Gauge (cannula) : 22 | 10 | In distribution |
| 333684 | Gauge (cannula) : 22 | 25 | In distribution |
| 4892710NR-02 | Gauge (cannula) : 20 | 10 | In distribution |
| 4892712-02 | Gauge (cannula) : 20 | 10 | In distribution |
| 4892705-02 | Gauge (cannula) : 22 | 10 | In distribution |
| 333674 | Gauge (cannula) : 22 | 25 | In distribution |
| 4892708-02 | Gauge (cannula) : 22 | 10 | In distribution |
| 333654 | Gauge (cannula) : 22 | 25 | Withdrawn |
| 333659 | 25 | Withdrawn | |
| 333650 | Gauge (cannula) : 22 | 25 | Withdrawn |
| 333660 | Gauge (cannula) : 20 | 25 | Withdrawn |
| 333656 | Gauge (cannula) : 22 | 25 | Withdrawn |
| 333652 | Gauge (cannula) : 22 | 25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | Avanos Medical, Inc. | 386 |
| Sprotte® | Pajunk Gmbh Medizintechnologie | 273 |
| Avanos | Avanos Medical, Inc. | 264 |
| Epimed | Epimed International, Inc. | 131 |
| Phoenix | DR. Japan Co., Ltd. | 128 |
| Tuohy | Pajunk Gmbh Medizintechnologie | 128 |
| Lccs | Lccs Products Limited | 121 |
| Arrow | Teleflex Medical LLC | 104 |
| Reli | Myco Medical Supplies, Inc. | 86 |
| Sonoblock | Pajunk Gmbh Medizintechnologie | 70 |
| Temena | Temena GmbH | 67 |
| Sprotte® NRFit | Pajunk Gmbh Medizintechnologie | 63 |
Showing 12 of 149. All products under Needle, Conduction, Anesthetic (W/Wo Introducer)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133632 | 2014-06-27 |
| K121846 | 2012-11-20 |
| K112515 | 2011-12-22 |
| K100241 | 2010-04-16 |
| K013610 | 2002-01-25 |
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.