Starlight Imaging Catheter
Basic Information
- Brand Name
- Starlight Imaging Catheter
- Primary DI
- 00860008045508
- Version / Model
- 951
- Catalog Number
- 951
- Company Name
- Spectrawave, Inc.
- Labeler DUNS
- 117899663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-23
- Public Version
- 1
- Public Version Date
- 2024-03-04
- Public Version Status
- New
- Public Device Record Key
- 16cfd144-aac0-482e-b9a8-6e69fedea170
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | Radiology | 892.1560 | 2 |
| ORD | Optical Coherence Tomography, Intravascular Catheter | Cardiovascular | 870.1200 | 2 |
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | Cardiovascular | 870.1200 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860008045508 | GS1 |
Customer Contacts
- Phone
- 3234016480
- [email protected]