AccessGUDID - DEVICE: Niobe Cover Drape (M58800100591011)

GUDID

Device Identifier (DI) Information

Brand Name: Niobe Cover Drape
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001-005910-1
Company Name: Stereotaxis, Inc.

Primary DI Number: M58800100591011
Issuing Agency: HIBCC
Commercial Distribution End Date: August 01, 2016
Device Count: 10
Labeler D-U-N-S® Number*: 024942265 *Terms of Use

Device Description: Stereotaxis Niobe Magnetic Navigation System (MNS) with Navigant Navigation Workstation. The Niobe MNS with Navigant NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature 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?
31742	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060967	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep Away from Sunlight
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d468506d-f52e-4479-9047-6b586a2bc2b4
Public Version Date: July 17, 2024
Public Version Number: 4
DI Record Publish Date: August 01, 2016