Catalog Number

EST1814F

Brand Name

Esophageal TTS Stent

Version/Model Number

EST1814F

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

K113551

Product Code

ESW

Product Code Name

Prosthesis, Esophageal

Public Device Record Key

532e9293-f41f-42b9-a1d8-1753cd11700f

Public Version Date

October 26, 2021

Public Version Number

5

DI Record Publish Date

September 10, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-