AccessGUDID - DEVICE: microTargeting™ Stylet (00873263002377)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Stylet
Version or Model: 66-ST-14P-00237
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 66-ST-14P
Company Name: FHC, INC.

Primary DI Number: 00873263002377
Issuing Agency: GS1
Commercial Distribution End Date: February 11, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting DP Stylet, 1x, nonsterile, for use with mT Drive and STar 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
Outer Diameter: 1.83 Millimeter
Length: 204 Millimeter

Device Record Status

Public Device Record Key: dad32deb-7c8f-46f9-be46-54d4e259e093
Public Version Date: February 12, 2021
Public Version Number: 4
DI Record Publish Date: September 17, 2016