Catalog Number

OT-CDU2P

Brand Name

OARtrac

Version/Model Number

OT-CDU2P

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

K182395,K182395

Product Code

NZT

Product Code Name

Dosimeter, Ionizing Radiation, Implanted

Public Device Record Key

b62a0783-df74-4e78-b259-34f2c20f4923

Public Version Date

July 11, 2019

Public Version Number

1

DI Record Publish Date

July 03, 2019

Package DI Number

20851546007190

Quantity per Package

1

Contains DI Package

00851546007196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case