DEVICE: microTargeting™ Drive System (00873263003503)

Device Identifier (DI) Information

microTargeting™ Drive System
MT-DS-01-00350
In Commercial Distribution
MT-DS-01
FHC, INC.
00873263003503
GS1

1
108179458 *Terms of Use
microTargeting(TM) Drive System compatible with mT Controller Contains: - Verification Probe - microTargeting(TM) Drive - Drive mount and Guide - microTargeting(TM) Sterilization Case - DBS Measurment Fixture - DBS Adapter for microTargeting(TM) Drive - Matrix Guide Bushings - Lumen Cleaning Tool - Accessories kit
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46863 Neurosurgical micro targeting drive
A calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HAW Neurological stereotaxic Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011775 000
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Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Moist Heat or Steam Sterilization
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -34 and 57 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

5904e18a-6df2-4c12-9e45-af5f4edd36ce
July 06, 2018
3
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)326-2905
fhcinc@fh-co.com
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