Catalog Number

EQD0504

Brand Name

Dornier MedTech

Version/Model Number

Equinox Ureteral Dilatation Balloon, 5mm x 4cm

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

EZN

Product Code Name

Dilator, Catheter, Ureteral

Public Device Record Key

b5425a84-a202-434a-a854-b4af6c4ad90a

Public Version Date

March 04, 2020

Public Version Number

1

DI Record Publish Date

February 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-