AccessGUDID - DEVICE: microTargeting™ Insertion Tube (10873263007614)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Insertion Tube
Version or Model: FC1018-00761
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FC1018
Company Name: FHC, INC.

Primary DI Number: 10873263007614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Array Electrode Insertion Tube with Stylet, Sterile, 5x for use with mT Drive Includes and one IT(AR1) and one IT(AR2). Individual Specifications: IT(AR1): Length=239.9mm, OD=0.88mm, ID=0.58mm IT(AR2): OD=1.83mm, ID=0.97mm (does not enter brain)

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:	Yes
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?
62753	Intracerebral cannula, nonimplantable, single-use	A sterile, nonimplantable, rigid tube intended to be surgically inserted through the skull to access the brain (e.g., cerebral ventricles) for cerebrospinal fluid (CSF) drainage, infusion of materials, and/or for use as a port through which instruments, leads and/or probes can be passed to perform a variety of diagnostic, treatment, or surgical procedures. It is usually made of metal (e.g., stainless steel) and may include a stylet/trocar blade. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46df63eb-ffe6-4d8e-b47d-02dcc62825fe
Public Version Date: January 06, 2020
Public Version Number: 1
DI Record Publish Date: December 27, 2019