AccessGUDID - DEVICE: microTargeting™ Insertion Tube (10873263001131)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Insertion Tube
Version or Model: FC1019-00113
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FC1019
Company Name: FHC, INC.

Primary DI Number: 10873263001131
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Array Lead Electrode Insertion Tube with Stylet, 5x, Sterile, for use with STar and MT Drive

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
61964	Intracerebral cannula, implantable	A sterile, implantable tube intended to be surgically placed in a specific area of the brain (e.g., basal ganglia) to position a deep brain electrical stimulation lead/electrode, using a stereotactic surgery system, and to function as a guide for subsequent and regular placement and/or removal of the lead/electrode. It is made of synthetic polymer materials (e.g., polyurethane) and may include a stylet/trocar blade.	Active	true

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 [?]
Moist Heat or Steam Sterilization
Ethylene Oxide

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 1.6 Millimeter
Length: 243.5 Millimeter
Outer Diameter: 1.83 Millimeter

Device Record Status

Public Device Record Key: 2c7a93c0-ffa4-4150-a25d-9ace3e89667c
Public Version Date: January 10, 2023
Public Version Number: 5
DI Record Publish Date: August 22, 2016