Gertie Marx Spinal N
Epidural Needle
9manufacturers in China registered for this device type
37catalogue 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 | International Medical Development, 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 | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K170112 |
| Record published | 2023-09-01 |
| Record revised | 2023-12-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FNB2090-I-8 | In distribution | |
| GM2290-I | In distribution | |
| GM25124-I | In distribution | |
| EP175 | In distribution | |
| GM24124-I | In distribution | |
| GM2650-I | In distribution | |
| EP1735 | In distribution | |
| GM2450-I | In distribution | |
| GM22190-I | In distribution | |
| GM22124-I | In distribution | |
| GM2790-I | In distribution | |
| GM22150-I | In distribution | |
| EP176 | In distribution | |
| GM27124-I | In distribution | |
| GM2690-I | In distribution | |
| GM2250-I | In distribution | |
| EP177 | In distribution | |
| GM2590-I | In distribution | |
| GM25190176 | In distribution | |
| GM2750-I | In distribution | |
| GM2270-I | In distribution | |
| GM24101-I | In distribution | |
| GM27160-I | In distribution | |
| GM26101-I | In distribution | |
| GM2490-I | In distribution | |
| GM2550-I | In distribution | |
| GM25215177 | In distribution | |
| GM25160175 | In distribution | |
| GM25101-I | In distribution | |
| GM2550-I | In distribution | |
| GM26124-I | In distribution | |
| GM25215-I | In distribution | |
| GM27150-I | In distribution | |
| GM25160-I | In distribution | |
| GM25190-I | In distribution | |
| GM27101-I | In distribution | |
| GM261241735 | 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 |
|---|---|
| K070354 | 2007-10-05 |
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.