DEVICE: Niobe MNS Philips (M58800100610010)

Device Identifier (DI) Information

Niobe MNS Philips
ES Philips
In Commercial Distribution
001-006100-1
STEREOTAXIS, INC.
M58800100610010
HIBCC

1
024942265 *Terms of Use
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
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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.
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FDA Product Code

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

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

42d65308-245f-4c8e-9a43-559157384413
July 06, 2018
3
August 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
13146786100
info@stereotaxis.com
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