Catalog Number

MERI3515S

Brand Name

Dornier MedTech

Version/Model Number

Dual Flex with Hydrophilic Tip, Straight, Stiff

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

EYA

Product Code Name

Stylet, Ureteral

Public Device Record Key

0bae35e2-205d-479b-9659-6fbc371c39d6

Public Version Date

February 26, 2020

Public Version Number

1

DI Record Publish Date

February 18, 2020

Package DI Number

00810116021918

Quantity per Package

5

Contains DI Package

00810116021901

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box