Catalog Number

27TS-21-EN

Brand Name

SteriPath Gen2, 21G, TS

Version/Model Number

27TS-21-EN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K192247,K192247

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

ed8c265b-c69a-436e-9703-014656a006c1

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

November 06, 2020

Package DI Number

10858366007204

Quantity per Package

10

Contains DI Package

00858366007207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Sales Pack