Catalog Number

FTSXCVRSM

Brand Name

Dornier MedTech

Version/Model Number

Equipment Cover (X-Ray Footswitch)

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"

Yes

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

-

Product Code

IZI

Product Code Name

System, X-Ray, Angiographic

Public Device Record Key

0d3fef77-a9fd-4caf-bce6-2f3c4aa09b26

Public Version Date

March 25, 2020

Public Version Number

1

DI Record Publish Date

March 17, 2020

Package DI Number

10810116023018

Quantity per Package

100

Contains DI Package

00810116023011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box