Catalog Number

10003

Brand Name

DCTclock

Version/Model Number

10003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

PTY

Product Code Name

Computerized Cognitive Assessment Aid, Exempt

Public Device Record Key

824307cb-0dc1-4b4c-9636-36df0acf16f6

Public Version Date

August 06, 2020

Public Version Number

3

DI Record Publish Date

February 16, 2018

Package DI Number

B626100031

Quantity per Package

25

Contains DI Package

B626100030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shrink wrap