Catalog Number

EPX18

Brand Name

Elation 5™

Version/Model Number

00884450487129

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

85cc5be0-b4c9-41c3-bbe6-2642b956142d

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

10884450487126

Quantity per Package

20

Contains DI Package

00884450487129

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-