Catalog Number

-

Brand Name

Exoflex 53in. T-Extension Set

Version/Model Number

95789

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

K162304,K162304

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

51fc9464-d74f-4d55-af80-9d0ae9cf1b9a

Public Version Date

March 20, 2019

Public Version Number

1

DI Record Publish Date

March 12, 2019

Package DI Number

20634624957897

Quantity per Package

50

Contains DI Package

00634624957893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-