FDA UDI
In Commercial Distribution
🇺🇸 United States
Genesis MNS with Model-S
DI: M58800101100030
·
Model: 1.1 Model-S
·
STEREOTAXIS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Genesis MNS with Model-S
- Primary DI
- M58800101100030
- Version / Model
- 1.1 Model-S
- Catalog Number
- 001-011000-3
- Company Name
- STEREOTAXIS, INC.
- Labeler DUNS
- 024942265
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-20
- Public Version
- 1
- Public Version Date
- 2020-08-28
- Public Version Status
- New
- Public Device Record Key
- 888c8dad-7934-4641-810e-6a929b829ae8
Device Description
"Genesis MNS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart and coronary vasculature, neurovascular and peripheral vasculature by orienting the device tip in a desired direction. "
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PJB | Catheter Remote Control System | Cardiovascular | 870.5700 | 2 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | Cardiovascular | 870.1290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38723 | Robotic surgical navigation system | An assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M58800101100030 | HIBCC |
Customer Contacts
- Phone
- 13146786100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193147 | 000 |