Spinaut-E
Spinaut-E is a steerable epidural catheter for delivery of drugs indicated for the epidural space. It combines a flexible catheter, steering handle and lumen access port that connects to a…
Spinaut-E is a steerable epidural catheter for delivery of drugs indicated for the epidural space. It combines a flexible catheter, steering handle and lumen access port that connects to a syringe.
The soft tip can be directed through the epidural space. E1000, E2000 and E3000 models bend 50 degrees left or right, while E1100, E2100 and E3100 models provide up to 100 degrees of bending.
Port Options and Supply
S1000, S2000 and S3000 versions add a separate drug infusion port so the main port can accommodate another device. Models also vary in dimensions and lever configuration. Spinaut-E is supplied sterile for single use.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
Record
| Listed by | Imedicom Co., Ltd., South Korea |
|---|---|
| FDA product code | BSO |
| Device type | Catheter, Conduction, Anesthetic |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5120 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K150789 |
| Record published | 2016-12-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S3000 | In distribution | |
| E3000 | In distribution | |
| E1100 | In distribution | |
| E1000 | In distribution | |
| E2000 | In distribution | |
| S2000 | In distribution | |
| E2100 | In distribution | |
| S1000 | In distribution | |
| E3100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 366 |
| Epimed | Epimed International, Inc. | 56 |
| Avanos | Avanos Medical, Inc. | 48 |
| E-Cath Tsui | Pajunk Gmbh Medizintechnologie | 47 |
| Halyard | Avanos Medical, Inc. | 34 |
| Infiltralong | Pajunk Gmbh Medizintechnologie | 25 |
| E-Cath acc. Tsui | Pajunk Gmbh Medizintechnologie | 21 |
| E-Cath Plus acc. Tsui | Pajunk Gmbh Medizintechnologie | 17 |
| Epinaut | Imedicom Co., Ltd. | 16 |
| E-Cath® Plus Tsui® | Pajunk Gmbh Medizintechnologie | 10 |
| E-Cath® II Tsui® | Pajunk Gmbh Medizintechnologie | 9 |
| E-Cath® NRFit Tsui® | Pajunk Gmbh Medizintechnologie | 6 |
Showing 12 of 65. All products under Catheter, Conduction, Anesthetic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173541 | 2018-08-24 |
| K150789 | 2016-03-01 |
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.