Catalog Number

01-124110

Brand Name

D3 Fastpoint

Version/Model Number

01-124110

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

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

LJG

Product Code Name

QUALITY CONTROL SLIDES

Public Device Record Key

8bb0eff1-7acd-492d-9064-c413ae6d58a9

Public Version Date

May 01, 2019

Public Version Number

1

DI Record Publish Date

April 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-