Catalog Number

AS861006

Brand Name

AMSure® PVC Intermittent 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)

-

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

-

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

-

FDA Premarket Submission

-

Product Code

EZD

Product Code Name

Catheter, Straight

Public Device Record Key

b41bda9d-865f-4c81-bfca-5a75b2846d94

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

40704411003671

Quantity per Package

50

Contains DI Package

10704411003670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case