AccessGUDID - DEVICE: Starlight Imaging Catheter (00860008045508)

GUDID

Device Identifier (DI) Information

Brand Name: Starlight Imaging Catheter
Version or Model: 951
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 951
Company Name: Spectrawave, Inc.

Primary DI Number: 00860008045508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117899663 *Terms of Use

Device Description: The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components: • Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console. • Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.

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:	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?
64434	Intravascular near-infrared spectroscopy imaging system catheter	A fibreoptic flexible tube intended to be percutaneously introduced into the vasculature (e.g., peripheral vessels, coronary arteries) to perform near-infrared spectroscopy [NIRS] for intravascular examination, especially for detection and image-based quantification of lipid core plaques. Its proximal end connects to a parent spectroscopy system for the transmission of light signals for viewing and analysis. This is a single-use device.	Active	false
47491	Coronary optical coherence tomography system catheter	A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQQ	System, Imaging, Optical Coherence Tomography (Oct)
ORD	Optical Coherence Tomography, Intravascular Catheter
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation
IYO	System, Imaging, Pulsed Echo, Ultrasonic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 16cfd144-aac0-482e-b9a8-6e69fedea170
Public Version Date: March 04, 2024
Public Version Number: 1
DI Record Publish Date: February 23, 2024