AccessGUDID - DEVICE: microTargeting™ Insertion Tube with Stylet (00873263005217)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Insertion Tube with Stylet
Version or Model: 66-IT(DB12)-00521
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66-IT(DB12)
Company Name: FHC, INC.

Primary DI Number: 00873263005217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Insertion Tube with Stylet, nonsterile, at target, for use with Nexframe/Nexdrive

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:	No
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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 1.6 Millimeter
Outer Diameter: 1.83 Millimeter
Length: 211.6 Millimeter

Device Record Status

Public Device Record Key: 278047e6-3d67-4961-ae97-db33bbe05802
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 17, 2016