Porges Coloplast - X-FLOW® Prostatectomy catheter Delinotte tip - Coloplast A/S

Duns Number:305524696

Device Description: X-FLOW® Prostatectomy catheter Delinotte tip 3-way 30-50 ml 100% silicone CH FR 18

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More Product Details

Catalog Number

AB6218

Brand Name

Porges Coloplast

Version/Model Number

AB6218

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K013172,K013172

Product Code Details

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Device Record Status

Public Device Record Key

deea34c1-fe1d-41ff-99ad-5b1c67faf99f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

03600040143995

Quantity per Package

5

Contains DI Package

03600040143988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Retail box

"COLOPLAST A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 899
3 A medical device with high risk that requires premarket approval 72
U Unclassified 7