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

-

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

404ab904-bed3-4df1-97f1-f3a7d8fd8c77

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

10817640020506

Quantity per Package

5

Contains DI Package

00817640020509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser