Catalog Number

-

Brand Name

Orion II

Version/Model Number

A33-05116

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

FOZ

Product Code Name

Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Public Device Record Key

b90b387e-2746-428e-9f52-4d091432ae1f

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

January 30, 2018

Package DI Number

20876604001576

Quantity per Package

4

Contains DI Package

10876604001579

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case