AccessGUDID - DEVICE: STar™ Drive Insertion Tube Set (00873263002186)

GUDID

Device Identifier (DI) Information

Brand Name: STar™ Drive Insertion Tube Set
Version or Model: 70-IT-04-00218
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70-IT-04
Company Name: FHC, INC.

Primary DI Number: 00873263002186
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 108179458 *Terms of Use

Device Description: STar(TM) Drive Array Electrode Insertion Tube Set for use with microTargeting(TM) Platform, non-sterile Set Contains: 6x IT(AR18) Guide Tube, 1.83mm OD (does not enter brain) 6x IT(AR19) Insertion Tube with Stylet - 186.7mm length, 0.87mm od, 0.60mm id 1x IT(AR4) DBS Lead Insertion Tube with Stylet - 188.05mm length, 1.83mm od, 1.60mm id. 2x Insertion Tube Extractors

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?
61854	Intracerebral cannula, nonimplantable, reusable	A 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 reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAO	INSTRUMENT, SURGICAL, NON-POWERED
HAW	Neurological stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40014ed6-df86-4dd3-9f4f-c426e4ec803b
Public Version Date: December 09, 2022
Public Version Number: 3
DI Record Publish Date: September 17, 2016