Catalog Number

-

Brand Name

Maquet ORCHIDE

Version/Model Number

ARD569204940

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 25, 2022

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KQM

Product Code Name

Camera, Surgical And Accessories

Public Device Record Key

444f9fdd-afbf-4824-8129-006326622f72

Public Version Date

February 28, 2022

Public Version Number

2

DI Record Publish Date

September 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-