Catalog Number

B319516AM

Brand Name

SureStep™ Foley System Lubri-Sil® I.C. Complete Care® Temp Sensing Catheter Tray

Version/Model Number

B319516AM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

9c6711ab-95c6-4a23-bbc2-99912e790b04

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

April 27, 2017

Package DI Number

10801741099714

Quantity per Package

10

Contains DI Package

00801741099717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA