Catalog Number

PS2-1S

Brand Name

Posi-Stick Introducer Set

Version/Model Number

PS2-1S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 01, 2027

Issuing Agency

In HIBCC

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

ecd7ad12-30e1-4be3-b68a-4a60217fe963

Public Version Date

June 06, 2022

Public Version Number

2

DI Record Publish Date

June 19, 2019

Package DI Number

H862PS21SNC2

Quantity per Package

10

Contains DI Package

H862PS21SNC1

Package Discontinue Date

February 01, 2027

Package Status

In Commercial Distribution

Package Type

Shipper