OPTISi™ 1014941

GUDID 05415067036810

Coronary optical coherence tomography system

Primary Device ID	05415067036810
NIH Device Record Key	87d7a901-3607-4aae-b874-a2d5e1efcb4c
Commercial Distribution Status	In Commercial Distribution
Brand Name	OPTISi™
Version Model Number	1014941
Catalog Number	1014941
Company DUNS	149818952
Company Name	ST. JUDE MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	05415067036810 [Primary]

NQQ	SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT)

Steralize Prior To Use	false
Device Is Sterile	false

05415067051226 - EnSite™	2025-08-25 X EP System Display Workstation
05415067051233 - NA	2025-08-25 ADAS 3D Base License Software License
05415067051257 - EnSite™	2025-08-25 X EP System Display Workstation
05415067051264 - NA	2025-08-25 ADAS 3D LA License Software License
05415067051295 - NA	2025-08-25 ADAS 3D LV License Temporary Software License
05415067051301 - NA	2025-08-25 ADAS 3D LV License Software License
05415067051318 - NA	2025-08-25 ADAS 3D LA License Temporary Software License
05415067051646 - EnSite™	2025-08-25 X EP System PFA ECG Signal Splitter