Tuohy Epidural Needle
18 ga (1.3 mm) x 13 cm
9manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
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 | Remington 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, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner carton of 10, shipping carton of 10, shipping carton of 8 |
| Sizes | Needle gauge 17 to 22 G |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TNMR-1805 | Needle Gauge 18 G | In distribution | |
| TNMF-1803NS | Needle Gauge 18 G | 125 | In distribution |
| TNMR-1705NS | Needle Gauge 17 G | 125 | In distribution |
| TNMR-1902NS | Needle Gauge 19 G | 125 | In distribution |
| TNMF-1803 | Needle Gauge 18 G | In distribution | |
| TNMF-1703 | Needle Gauge 17 G | In distribution | |
| TNMR-1705 | Needle Gauge 17 G | In distribution | |
| TNMF-1705NS | Needle Gauge 17 G | 125 | In distribution |
| TNMR-2203 | Needle Gauge 22 G | In distribution | |
| TNMF-2005 | Needle Gauge 20 G | In distribution | |
| TNMF-2005NS | Needle Gauge 20 G | 125 | In distribution |
| TNMF-2006NS | Needle Gauge 20 G | 125 | In distribution |
| TNMF-2203NS | Needle Gauge 22 G | 125 | In distribution |
| TNMR-1703 | Needle Gauge 17 G | In distribution | |
| TNMF-2203 | Needle Gauge 22 G | In distribution | |
| TNMF-2006 | Needle Gauge 20 G | In distribution | |
| TNMR-2005NS | Needle Gauge 20 G | 125 | In distribution |
| TNMF-1805 | Needle Gauge 18 G | In distribution | |
| TNMF-1805NS | Needle Gauge 18 G | 125 | In distribution |
| TNMR-2203NS | Needle Gauge 22 G | 125 | In distribution |
| TNMR-1703NS | Needle Gauge 17 G | 125 | In distribution |
| TNMF-1902 | Needle Gauge 19 G | In distribution | |
| TNMR-1902 | Needle Gauge 19 G | In distribution | |
| TNMF-1902NS | Needle Gauge 19 G | 125 | In distribution |
| TNMR-2003NS | Needle Gauge 20 G | 125 | In distribution |
| TNMR-1803NS | Needle Gauge 18 G | 125 | In distribution |
| TNMR-1805NS | Needle Gauge 18 G | 125 | In distribution |
| TNMF-1703NS | Needle Gauge 17 G | 125 | In distribution |
| TNMR-2006NS | Needle Gauge 20 G | 125 | In distribution |
| TNMR-2003 | Needle Gauge 20 G | In distribution | |
| TNMF-2003NS | Needle Gauge 20 G | 125 | In distribution |
| TNMR-2006 | Needle Gauge 20 G | In distribution | |
| TNMF-2003 | Needle Gauge 20 G | In distribution | |
| TNMF-1705 | Needle Gauge 17 G | In distribution | |
| TNMR-2005 | Needle Gauge 20 G | In distribution | |
| TNMR-1803 | Needle Gauge 18 G | 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 |
|---|---|
| K150266 | 2015-06-04 |
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.