Catalog Number

OT1-PSD-2U

Brand Name

OARtrac

Version/Model Number

OT1-PSD-2U

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

K150719,K150719,K150719

Product Code

NZT

Product Code Name

Dosimeter, Ionizing Radiation, Implanted

Public Device Record Key

b6235f4a-1522-4ffa-9c50-deb251ea747b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20851546007077

Quantity per Package

5

Contains DI Package

10851546007070

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box