Catalog Number

00711145

Brand Name

Entrada

Version/Model Number

00711145

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 25, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FED

Product Code Name

endoscopic access overtube, gastroenterology-urology

Public Device Record Key

dceb1673-7b20-4821-8e91-92a5bc788bac

Public Version Date

March 25, 2019

Public Version Number

3

DI Record Publish Date

September 17, 2016

Package DI Number

10816765011192

Quantity per Package

3

Contains DI Package

00816765011195

Package Discontinue Date

March 25, 2019

Package Status

Not in Commercial Distribution

Package Type

Box