Catalog Number

0014640-0014

Brand Name

DORADO

Version/Model Number

DORADOnova blue wall

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"

-

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

IWE

Product Code Name

Monitor, Patient Position, Light-Beam

Public Device Record Key

ef86fd5e-00ea-452a-b985-34fb1fabbbf2

Public Version Date

February 01, 2019

Public Version Number

1

DI Record Publish Date

January 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-