Medline - CATHETER, URETHRAL, COUDE, VINYL, 12 - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: CATHETER, URETHRAL, COUDE, VINYL, 12

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More Product Details

Catalog Number

URO3PVC1216C

Brand Name

Medline

Version/Model Number

URO3PVC1216C

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

-

Product Code Details

Product Code

EZD

Product Code Name

CATHETER, STRAIGHT

Device Record Status

Public Device Record Key

32094da0-cdfc-4f8c-85ec-106f775a65d0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

40884389196718

Quantity per Package

30

Contains DI Package

10884389196717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7