Catalog Number

-

Brand Name

Uro-EZDilate KIT 18Fr (6mm) x 10cm URETERAL BALLOON DILATION CATHETER

Version/Model Number

BURS0610K

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K132181

Product Code

KOE

Product Code Name

DILATOR, URETHRAL

Public Device Record Key

0eda9c0b-a378-4cc3-8da4-88bd32a8f7a2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-