Catalog Number

21000-30

Brand Name

Insitu - ONTRAC PTCA Endoflator

Version/Model Number

QL® 2030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2020

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

-

Product Code

MAV

Product Code Name

Syringe, Balloon Inflation

Public Device Record Key

016e7910-12dc-4c96-bad4-887a18f3fd9f

Public Version Date

October 09, 2020

Public Version Number

6

DI Record Publish Date

September 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-