OPTIS™

Basic Information

• Brand Name: OPTIS™
• Primary DI: 05415067036742
• Version / Model: 1014934
• Catalog Number: 1014934
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-10
• Public Version: 2
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: e84b5ca7-0531-4b62-822e-4f4851c2ac6a

Device Description

Mobile Next Upgrade Kit

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NQQ	SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47490	Coronary optical coherence tomography system	An assembly of optical and computer-based devices that use a broad-bandwidth light beam for optical coherence tomography (OCT) to provide high-resolution images (e.g., 5 to 40 microns) of the coronary intravasculature. It typically consists of a main operator's console which includes a computer for image storage, keyboard/mouse controls, and a visual display unit (VDU); audio recording facilities; and a printer. The system includes an optical-imaging catheter which is connected to the console for transmission of the images from the intravascular site. The system may be used during interventional cardiology, radiology, or diagnostic angiography.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067036742	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210458	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 25 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 25 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius