Catalog Number

-

Brand Name

EAR HOLDER COVERS

Version/Model Number

208224

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

K180947

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

c65a061d-837d-4bec-a95e-af4fb887ea7d

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

February 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-