Novasight Hybrid™ Catheter

GUDID 01628055603053

Coronary optical coherence tomography system catheter

Primary Device ID	01628055603053
NIH Device Record Key	317f7c4b-71aa-4c7b-ba9f-893d3157ef82
Commercial Distribution Status	In Commercial Distribution
Brand Name	Novasight Hybrid™ Catheter
Version Model Number	TA-06-0001
Company DUNS	200125243
Company Name	Conavi 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	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	true
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	00628055603054 [Primary]
GS1	01628055603053 [Package] Contains: 00628055603054 Package: [1 Units] In Commercial Distribution
GS1	05628055603059 [Package] Contains: 00628055603054 Package: [5 Units] In Commercial Distribution
GS1	10628055603051 [Package] Contains: 00628055603054 Package: [10 Units] In Commercial Distribution

OBJ	Catheter, Ultrasound, Intravascular

Steralize Prior To Use	false
Device Is Sterile	true

01628055603053	Imaging catheter
00628055603115	Imaging catheter consists of Novasight Hybrid Catheter, Accessory Pack and PIM Bag.

Mark Image Registration \| Serial	Company Trademark Application Date
NOVASIGHT HYBRID 88033734 not registered Live/Pending	Conavi Medical Inc. 2018-07-11