AccessGUDID - DEVICE: microTargeting Insertion Tube (00873263003497)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting Insertion Tube
Version or Model: 66-IT-AR4P-00349
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66-IT-AR4P
Company Name: FHC, INC.

Primary DI Number: 00873263003497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Lead Insertion Tube with Stylet, Sterile, for use with microTargeting Platform

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 [?]
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
Length: 188 Millimeter
Lumen/Inner Diameter: 1.6 Millimeter
Outer Diameter: 1.83 Millimeter

Device Record Status

Public Device Record Key: 195a4ff8-3a0e-441b-bd82-6127eb9451e5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 17, 2016