Catalog Number

-

Brand Name

CURE ULTRAPLUS CATHETER

Version/Model Number

ULTRAPlus8

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

K080881,K080881,K080881

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

63dfc1af-174f-4f92-9a69-f70afb06ab88

Public Version Date

October 19, 2022

Public Version Number

2

DI Record Publish Date

April 19, 2022

Package DI Number

10815947021332

Quantity per Package

30

Contains DI Package

00815947021335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Carton