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

Duns Number:809784593

Device Description: Closed System Complete Urinary Catheterization System with Catheter Control Feature, Strai Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Tip

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More Product Details

Catalog Number

-

Brand Name

Cure Catheter® Closed System

Version/Model Number

CSL16

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

63c5ed48-1e4f-4462-9403-67a59d53b8a1

Public Version Date

February 02, 2022

Public Version Number

4

DI Record Publish Date

December 31, 2017

Additional Identifiers

Package DI Number

10815947020861

Quantity per Package

100

Contains DI Package

00815947020864

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