Catalog Number

IQA509

Brand Name

InQwire® Amplatz

Version/Model Number

00884450239803

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170700,K170700,K170700

Product Code

DQX

Product Code Name

WIRE, GUIDE, CATHETER

Public Device Record Key

95c65d75-edd9-4be2-b7c1-b4a37b742598

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 05, 2017

Package DI Number

10884450239800

Quantity per Package

5

Contains DI Package

00884450239803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-