Catalog Number

EPX10

Brand Name

Elation 5™

Version/Model Number

00884450487082

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

3d886880-26ac-4da3-aa4d-d31baf94a664

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 04, 2021

Package DI Number

10884450487089

Quantity per Package

20

Contains DI Package

00884450487082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-