Catalog Number

EPCX8

Brand Name

Elation 5™

Version/Model Number

00884450487150

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

KNQ

Product Code Name

Dilator, esophageal

Public Device Record Key

a15a4df9-7a52-4f37-a03a-1b8bc527d20f

Public Version Date

July 29, 2021

Public Version Number

1

DI Record Publish Date

July 21, 2021

Package DI Number

10884450487157

Quantity per Package

20

Contains DI Package

00884450487150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-