Catalog Number

AS44010

Brand Name

AMSure® Red Rubber Urethral Catheter

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

EYB

Product Code Name

Catheter, Ureteral, Gastro-Urology

Public Device Record Key

e139b941-e3eb-426e-9634-c11104677994

Public Version Date

December 23, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

30704411001793

Quantity per Package

100

Contains DI Package

10704411001799

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box