NA - 3.5Fr Silicone Urinary Drainage Catheter - FOOTPRINT MEDICAL, INC.

Duns Number:791238046

Device Description: 3.5Fr Silicone Urinary Drainage Catheter

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

S1UDC3.5

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

K090576,K090576

Product Code Details

Product Code

EZD

Product Code Name

Catheter, Straight

Device Record Status

Public Device Record Key

6e894096-abb6-41e6-9e9e-96082f7783da

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

10858778006413

Quantity per Package

10

Contains DI Package

00858778006416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"FOOTPRINT MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 133