Catalog Number

4010-EN

Brand Name

Steripath Micro

Version/Model Number

4010-EN

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

7b7b612d-f0d4-47a7-b105-8b9055c20a10

Public Version Date

April 02, 2021

Public Version Number

1

DI Record Publish Date

March 25, 2021

Package DI Number

10858366007440

Quantity per Package

10

Contains DI Package

00858366007443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sales Pack