Catalog Number

AS87114K

Brand Name

AMSure® Urethral Catheterization 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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

FCM

Product Code Name

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

Public Device Record Key

cc904c4d-ccb6-4212-94bf-1fe4bafb29ac

Public Version Date

May 29, 2018

Public Version Number

1

DI Record Publish Date

April 28, 2018

Package DI Number

40704411007525

Quantity per Package

20

Contains DI Package

10704411007524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case