AccessGUDID - DEVICE: omniTRAX Patient Tracker Starter Kit (00841436101042)

GUDID

Device Identifier (DI) Information

Brand Name: omniTRAX Patient Tracker Starter Kit
Version or Model: 5438658
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5438658
Company Name: CIVCO MEDICAL INSTRUMENTS CO., INC.

Primary DI Number: 00841436101042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134614411 *Terms of Use

Device Description: Reusable non-sterile multi-modality fiducial markers (5), reusable non-sterile general purpose electromagnetic sensor for use with 3D Guidance driveBAY™, driveBAY™ 2™, trakSTAR™ or trakSTAR™ 2 trackers

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
58246	Electromagnetic device tracking system spatial marker	A non-powered, noninvasive device intended to provide a fixed reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure, whereby tracking images are overlaid on pre-acquired and/or real-time images [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US)]. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, imaging, pulsed echo, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092619	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 52 and 85 Degrees Fahrenheit
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
Width: 7 Inch
Length: 1.95 Inch

Device Record Status

Public Device Record Key: cf82057a-8340-4ba5-b36e-e67b816ad0ca
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: August 22, 2017