AccessGUDID - DEVICE: microTargeting™ Insertion Tube (10873263008079)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Insertion Tube
Version or Model: 66-IT-MR3-00807
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66-IT-MR3
Company Name: FHC, INC.

Primary DI Number: 10873263008079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting™ MR Lead Insertion Tube 1 mm above target with Ceramic Stylet at target, non-sterile, 2x

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 1.6 Millimeter
Outer Diameter: 1.8 Millimeter
Length: 210.85 Millimeter

Device Record Status

Public Device Record Key: d2ec7d65-777d-40c7-99b1-7d99656ef3a9
Public Version Date: January 08, 2020
Public Version Number: 1
DI Record Publish Date: December 31, 2019