Catalog Number

-

Brand Name

Novasight Hybrid™ Catheter

Version/Model Number

TA-06-0001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K172258,K172258,K172258,K172258

Product Code

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Public Device Record Key

317f7c4b-71aa-4c7b-ba9f-893d3157ef82

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Package DI Number

01628055603053

Quantity per Package

1

Contains DI Package

00628055603054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-