Catalog Number

-

Brand Name

CURE ULTRA CATHETER

Version/Model Number

ULTRA14

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"

Yes

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

K080881,K080881,K080881

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

f6143c63-bf7d-4e98-8d9c-c2fccb6c0e3e

Public Version Date

October 27, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20815947020448

Quantity per Package

10

Contains DI Package

10815947020441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case