Catalog Number

-

Brand Name

Set, Administration, Intravascular

Version/Model Number

EB-060-26

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2020

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

FDA

Product Code Name

Enteroscope And Accessories

Public Device Record Key

0c8d314f-0dfd-4db4-84d6-180446f70ac6

Public Version Date

February 07, 2020

Public Version Number

5

DI Record Publish Date

March 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-