Catalog Number

4667-

Brand Name

VALO

Version/Model Number

4667-

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

K132953

Product Code

PEM

Product Code Name

Dental barriers and sleeves

Public Device Record Key

956dd444-f28b-4293-9a22-23e975289fcb

Public Version Date

November 22, 2018

Public Version Number

2

DI Record Publish Date

June 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-