AccessGUDID - DEVICE: Genesis MNS with Model-S (M58800101100030)

GUDID

Device Identifier (DI) Information

Brand Name: Genesis MNS with Model-S
Version or Model: 1.1 Model-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001-011000-3
Company Name: Stereotaxis, Inc.

Primary DI Number: M58800101100030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024942265 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJB	Catheter Remote Control System
NDQ	System, Catheter Or Guidewire, Steerable (Magnetic)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193147	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 888c8dad-7934-4641-810e-6a929b829ae8
Public Version Date: July 17, 2024
Public Version Number: 2
DI Record Publish Date: August 20, 2020