Cure Catheter® Closed System - Closed System Complete Urinary Catheterization - CONVATEC, PURCHASING DEPARTMENT

Duns Number:809784593

Device Description: Closed System Complete Urinary Catheterization System, Straight Tip

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Cure Catheter® Closed System

Version/Model Number

CS10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2022

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

FCM

Product Code Name

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Device Record Status

Public Device Record Key

c1aa55bf-0cc2-4a78-bb88-fc5e4378d437

Public Version Date

February 02, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10815947020656

Quantity per Package

100

Contains DI Package

00815947020659

Package Discontinue Date

February 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"CONVATEC, PURCHASING DEPARTMENT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 116
U Unclassified 8