BD Quincke Spinal NRFit
BD Quincke Spinal NRFit is a spinal needle for fluid injection or withdrawal during lumbar puncture and myelography, including anesthesia. It is intended for adult and pediatric patients.…
BD Quincke Spinal NRFit is a spinal needle for fluid injection or withdrawal during lumbar puncture and myelography, including anesthesia. It is intended for adult and pediatric patients.
The hollow stainless-steel cannula is bonded to a polypropylene hub and supplied with a polypropylene shield. A solid stainless-steel stylet with a polymer handle occupies the needle lumen.
Listed Item
BD® Quincke Spinal NRFit™ Needle, 25G x 4 11/16 in.
Connector and Supply Options
The hub uses an ISO 80369-6 NRFit connector, with a yellow shield identifying the compatible connection family. Quincke needles range from 18G to 27G and 1.5 to 7 inches. Sterile, single-use versions are EO-sterilized; bulk nonsterile versions require sterilization before use.
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 | Becton, Dickinson AND Company, 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, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K193131 |
| Record published | 2022-06-01 |
| Record revised | 2025-11-10 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Fragile, handle with care; Special storage condition: Room Temperature |
| Packaging | Case of 4, pack or inner pack of 25, case of 5, pack or inner pack of 10 |
| Sizes | Length 1.5 to 7 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400989 | Length 1.5 in | In distribution |
| 400922 | Length 3.5 in | In distribution |
| 400062 | Length 2 in | In distribution |
| 400056 | Length 2.5 in | In distribution |
| 400924 | Length 3.5 in | In distribution |
| 400920 | Length 3 in | In distribution |
| 400053 | Length 3.5 in | In distribution |
| 400052 | Length 3 in | In distribution |
| 400059 | Length 5 in | In distribution |
| 400921 | Length 6 in | In distribution |
| 400181 | Length 3.5 in | In distribution |
| 400055 | Length 1.5 in | In distribution |
| 400923 | Length 3.5 in | In distribution |
| 400087 | Length 3 in | In distribution |
| 400990 | Length 1.5 in | In distribution |
| 400058 | Length 3.5 in | In distribution |
| 400057 | Length 3 in | In distribution |
| 400081 | Length 4.687 in | In distribution |
| 400054 | Length 6 in | In distribution |
| 400088 | Length 3.5 in | In distribution |
| 400060 | Length 7 in | In distribution |
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 |
|---|---|
| K211085 | 2022-07-01 |
| K210978 | 2021-12-22 |
| K193131 | 2020-09-29 |
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.