Catalog Number

IQA505

Brand Name

InQwire® Amplatz

Version/Model Number

00884450434628

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

e128a2d8-d18e-4645-968c-05017608619e

Public Version Date

March 10, 2020

Public Version Number

1

DI Record Publish Date

March 02, 2020

Package DI Number

20884450434622

Quantity per Package

20

Contains DI Package

10884450434625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-