Catalog Number

4232008-02

Brand Name

Introcan Safety ® 2

Version/Model Number

4232008-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

FOZ

Product Code Name

Catheter, intravascular, therapeutic, short-term less than 30 days

Public Device Record Key

f6e22295-f8ca-4872-8f46-a06b2ba3aa09

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 25, 2022

Package DI Number

04046955341948

Quantity per Package

4

Contains DI Package

04046955341931

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton