Novasight Hybrid™ Catheter

GUDID 01628055603053

Imaging catheter

Conavi Medical Inc

Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter Coronary optical coherence tomography system catheter 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

Customer Support Contacts

• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com
• Phone: 416-483-0100
• Email: customerservice@conavi.com

Device Identifiers

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

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172258

FDA Product Code

• OBJ: Catheter, Ultrasound, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-17
• Device Publish Date: 2020-09-09

On-Brand Devices [Novasight Hybrid™ Catheter]

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