Catalog Number

-

Brand Name

Candid Redo Impression Kit

Version/Model Number

RDLGORANGE00001

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

K821221

Product Code

EHY

Product Code Name

Tray, Impression, Preformed

Public Device Record Key

af908b19-34eb-4120-aded-d08cd6989449

Public Version Date

May 20, 2020

Public Version Number

2

DI Record Publish Date

March 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-