Catalog Number

AS89316S

Brand Name

AMSure® Foley Catheter Tray

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FCM

Product Code Name

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Public Device Record Key

07270782-4f04-4952-9548-9d6e7bcf9173

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

40704411005316

Quantity per Package

10

Contains DI Package

10704411005315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case