Catalog Number

-

Brand Name

Erkoloc-pro blu

Version/Model Number

595730

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

K200125

Product Code

KMY

Product Code Name

Positioner, Tooth, Preformed

Public Device Record Key

4c76556c-c4ec-4d1b-be4e-562567234b93

Public Version Date

September 02, 2021

Public Version Number

1

DI Record Publish Date

August 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-