Catalog Number

PS2-35SW

Brand Name

Posi-Stick Introducer Set

Version/Model Number

PS2-35SW

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 11, 2019

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

DYB

Product Code Name

Introducer, Catheter

Public Device Record Key

47abe65d-32c4-44e5-8df4-594467ba00bb

Public Version Date

September 12, 2019

Public Version Number

3

DI Record Publish Date

August 31, 2016

Package DI Number

H862PS235SW2

Quantity per Package

1

Contains DI Package

H862PS235SW1

Package Discontinue Date

September 11, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper