Catalog Number

80129-208/C

Brand Name

ALIMAXX-ES™

Version/Model Number

00884450038543

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

ESW

Product Code Name

PROSTHESIS, ESOPHAGEAL

Public Device Record Key

388d6387-59c9-47b1-8aa5-a84e4ad34a41

Public Version Date

November 08, 2021

Public Version Number

4

DI Record Publish Date

October 30, 2015

Package DI Number

10884450038540

Quantity per Package

1

Contains DI Package

00884450038543

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-