SonoPlex II Facet
SonoPlex II Facet is a nerve-block needle used to puncture tissue and inject local anaesthetic for regional anaesthesia. It is intended for ultrasound-guided placement, with an option to…
SonoPlex II Facet is a nerve-block needle used to puncture tissue and inject local anaesthetic for regional anaesthesia. It is intended for ultrasound-guided placement, with an option to apply an electrical stimulus to help the physician locate the application area.
The needle includes CornerStone reflectors to enhance its ultrasound visibility, an injection tube and a connecting cable. The cable and connector convey the localisation stimulus, while the tube provides the injection connection.
Listed Item
SonoPlex II Facet 21G (0,80) x 100mm, with injection tube and connecting cable
Needle Construction
The needle has a NanoLine parylene coating and is intended for a single use. The subject needle design includes a Facette tip configuration, matching the listed Facet needle.
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 | Pajunk Gmbh Medizintechnologie, Germany |
|---|---|
| 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, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer |
| 510(k) | K243682 |
| Record published | 2018-11-29 |
| Record revised | 2025-03-17 (version 3) |
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, manufacturing date |
| Storage | Storage environment humidity 20 to 65 % RH; Storage environment temperature 10 to 30 °C |
| Packaging | Pack of 10 |
| Sizes | Length 40 to 150 mm; outer diameter 0.7 to 0.9 mm; needle gauge 20 G |
| Distribution end date | 2025-03-15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 001285-77 | Outer Diameter 0.8 mm | In distribution | |
| 001285-71 | Outer Diameter 0.7 mm | In distribution | |
| 001285-95 | Length 100.0 mm | In distribution | |
| 001285-76 | Length 150.0 mm | In distribution | |
| 001285-74 | Outer Diameter 0.7 mm | In distribution | |
| 001285-70 | Length 40.0 mm | In distribution | |
| 001285-72 | Needle Gauge 20.0 G | In distribution | |
| 001285-78 | 10 | Withdrawn | |
| 001285-71 | 10 | Withdrawn | |
| 001285-70 | 10 | Withdrawn | |
| 001285-76 | 10 | Withdrawn | |
| 001285-74 | 10 | Withdrawn | |
| 001285-77 | 10 | Withdrawn | |
| 001285-75 | 10 | 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 |
|---|---|
| K243690 | 2025-07-01 |
| K243682 | 2025-06-27 |
| K250774 | 2025-06-25 |
| K243525 | 2025-03-24 |
| K241953 | 2024-11-22 |
| K241954 | 2024-09-11 |
| K170435 | 2017-07-12 |
| K160297 | 2016-10-28 |
| K160296 | 2016-10-27 |
| K160295 | 2016-10-27 |
| K160294 | 2016-10-21 |
| K111374 | 2011-08-29 |
| K063350 | 2008-02-01 |
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 |
|---|---|---|---|---|
| 2019-08-30 | Class II | Process control | Problem with packaging sealing process which affects sterility. | 40,475 devices |
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.