Catalog Number

-

Brand Name

BONASTENT® Esophageal

Version/Model Number

BE-1810

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)

Yes

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

K092144

Product Code

ESW

Product Code Name

Prosthesis, Esophageal

Public Device Record Key

98986fac-11d0-48ac-bfaa-1d5fc17d9433

Public Version Date

October 25, 2021

Public Version Number

4

DI Record Publish Date

March 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-