V-Loop Variable Loop Catheter Manipulator
- Primary DI
- M58800100245210
- Brand
- V-Loop Variable Loop Catheter Manipulator
- Company
- Stereotaxis, Inc.
- Model
- 1
- Catalog number
- 001-002452-1
- Device description
- The Vdrive with V-Loop disposable is indicated to remotely control the advancement, retraction, rotation, tip deflection and loop size of compatibile loop catheters inserted across the septum into the left atrium using conventional procedures
- Published
- 2016-05-02
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
stereotaxis.comProduct Codes#
Product Code Classifications#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| M58800100245210 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cardiac mapping system workstation | A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Keep Away from Sunlight |
| Special Storage Condition, Specify | 0 | 0 | Keep Dry |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| 13146786100 | info@stereotaxis.com |
Regulatory Flags#
- DUNS number
- 024942265
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
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|---|---|---|---|---|
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| M58800101400010 | GenesisX | 1 | 0010140001 | 2026-01-09 |
| M588001004115110 | Cardiodrive System | II | 001-004115-11 | 2022-06-06 |
| M588001004115120 | Cardiodrive System | II | 001-004115-12 | 2022-06-06 |
| M58800101100010 | Genesis (RMNS) | 1.1 | 001-011000-1 | 2020-08-20 |
| M58800101100030 | Genesis MNS with Model-S | 1.1 Model-S | 001-011000-3 | 2020-08-20 |
| M588020004500210 | Navigant | 4.6.4 | 020-004500-21 | 2016-08-01 |
| M588020004500220 | Navigant | 4.6.5 | 020-004500-22 | 2016-08-01 |
| M588020004500260 | Navigant | 5.0.2 | 020-004500-26 | 2016-10-27 |
| M58800100701020 | Odyssey | Quad HD | 001-007010-2 | 2016-08-01 |
| M58800100111411 | Hemostasis Adapter | IV-1 | 0010011141 | 2021-12-14 |
| M58802000780030 | Cinema MAS & MMS | DMS-100 | 020-007800-3 | 2016-08-01 |
| M58800100175110 | QuikCAS Cardiodrive Sterile Components | 1 | 001-001751-1 | 2016-05-02 |
| M5880010017711 | QuikCAS Hemostasis Adapter | 1 | 001-001771-1 | 2016-08-01 |
| M5880010017712 | Cardiodrive Hemostasis Adapter - SJ | 1 | 001-001771-2 | 2016-08-01 |
| M58800100230710 | Vdrive System | Single Arm | 001-002307-1 | 2016-08-01 |
| M58800100230720 | Vdrive System | Duo | 001-002307-2 | 2016-08-01 |
| M58800100242210 | V-CAS Catheter Advancement System | 1 | 001-002422-1 | 2016-05-02 |
| M58800100246910 | V-Sono Intracardiac Echo Manipulator | 1 | 001-002469-1 | 2016-05-02 |
| M58800100411590 | Cardiodrive System | II | 001-004115-9 | 2016-08-01 |
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