Catalog Number

-

Brand Name

Quantum™ Maverick™

Version/Model Number

H7493808115250

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

P860019,P860019,P860019,P860019,P860019,P860019,P860019

Product Code

LOX

Product Code Name

Catheters, transluminal coronary angioplasty, percutaneous

Public Device Record Key

e7a08fc2-ad2b-4a0b-9d0b-654da45d248e

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-