Cure Pocket XL™ - Sterile Intermittent Urinary Catheter with Clean - CONVATEC, PURCHASING DEPARTMENT

Duns Number:809784593

Device Description: Sterile Intermittent Urinary Catheter with Clean Sleeve and Lubricant Packet, Straight Tip

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More Product Details

Catalog Number

-

Brand Name

Cure Pocket XL™

Version/Model Number

M10XL

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

EZD

Product Code Name

Catheter, Straight

Device Record Status

Public Device Record Key

125ac19e-a40c-4adc-900a-a3c9f43f6d38

Public Version Date

February 02, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

20815947020721

Quantity per Package

10

Contains DI Package

10815947020724

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