SureStep™ Foley Tray System Bard® Silicone Foley Catheter - SureStep™ Foley Tray System Bard® Silicone Foley - C. R. Bard, Inc.

Duns Number:016898496

Device Description: SureStep™ Foley Tray System Bard® Silicone Foley Catheter Tray with Drainage Bag

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More Product Details

Catalog Number

A947418

Brand Name

SureStep™ Foley Tray System Bard® Silicone Foley Catheter

Version/Model Number

A947418

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Device Record Status

Public Device Record Key

95f0ac8a-3ea6-4e86-89b8-76d20b8f43e8

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

July 12, 2016

Additional Identifiers

Package DI Number

10801741100878

Quantity per Package

10

Contains DI Package

00801741100871

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA

"C. R. BARD, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 472
2 A medical device with a moderate to high risk that requires special controls. 1994
U Unclassified 10