AccessGUDID - DEVICE: microTargeting™ Insertion Tube Set (10873263007638)

GUDID

Device Identifier (DI) Information

Brand Name: microTargeting™ Insertion Tube Set
Version or Model: FC1036-00763
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FC1036
Company Name: FHC, INC.

Primary DI Number: 10873263007638
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: microTargeting Single electrode insertion tube set, sterile, 5x, 20mm above target. Contains: IT(BP5): Insertion Tube & Stylet - 199mm length, 1.83mm OD, 1.60mm ID PT(BP5): Protective Tube - 201mm length, 1.47mm OD, 0.99mm ID

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?
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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

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
No Device Sizes

Device Record Status

Public Device Record Key: e379a156-a2de-4e4a-a547-cec068387ad4
Public Version Date: January 08, 2020
Public Version Number: 1
DI Record Publish Date: December 31, 2019