M-Drain
The Percutaneous Introducer is used to dilate for placement of a .035” or .038” guide wire where the puncture is performed with a 21G needle (fine needle).
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Lifetech Scientific (Shenzhen) Co,.ltd | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Mermaid Medical A/S, Denmark |
|---|---|
| FDA product code | DRE |
| Device type | Dilator, Vessel, For Percutaneous Catheterization |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K071330 |
| Record published | 2016-09-24 |
| Record revised | 2023-10-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight and keep dry; Storage environment temperature -29 to 60 °C |
| Packaging | Retail box of 5 |
| Sizes | Length 20 cm; catheter gauge 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DS2010600 | Kit | In distribution |
| DS2020200 | Kit | In distribution |
| DS2010500 | Kit | In distribution |
| DS2010300 | Kit | In distribution |
| DS2020100 | Kit | In distribution |
| DS2020300 | Kit | In distribution |
| DS2010400 | Kit | In distribution |
| DS2010200 | Kit | In distribution |
| DS2020400 | Kit | In distribution |
| DS2010100 | Kit | In distribution |
| D20206020 | Length 20 cm | In distribution |
| D20106020 | Length 20 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prelude® | Merit Medical Systems, Inc. | 323 |
| Prelude PRO™ | Merit Medical Systems, Inc. | 132 |
| Cook | Cook Incorporated | 125 |
| Avanti | Cordis Corp. | 81 |
| Dilator, Vessel, For Percutaneous Catheterization | B. Braun Interventional Systems, Inc. | 59 |
| Merit MAK™ | Merit Medical Systems, Inc. | 49 |
| Prelude ACT™ | Merit Medical Systems, Inc. | 38 |
| AngioDynamics | Navilyst Medical, Inc. | 38 |
| Super Sheath | Togo Medikit Co., Ltd. | 31 |
| Avanti | Cordis US Corp. | 29 |
| Mini Stick MAX | AngioDynamics, Inc. | 28 |
| OneStic Micro-Access Introducer | Argon Medical Devices, Inc. | 27 |
Showing 12 of 159. All products under Dilator, Vessel, For Percutaneous Catheterization
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.