Catalog Number

8020XLG

Brand Name

ORALSURGE

Version/Model Number

8020XLG

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EHZ

Product Code Name

Evacuator, Oral Cavity

Public Device Record Key

c1dc9fc1-e6cd-4dbc-b740-413396678f89

Public Version Date

January 14, 2022

Public Version Number

1

DI Record Publish Date

January 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-