Catalog Number

D626DGC

Brand Name

Digitest™

Version/Model Number

D626DGC

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2018

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

-

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

EAT

Product Code Name

Tester, Pulp

Public Device Record Key

b4482507-0818-4758-8772-76390f045935

Public Version Date

October 11, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-