Catalog Number

11.1009.00

Brand Name

A-dec

Version/Model Number

11.1009.00

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

-

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

a4b3f0d4-5f61-46d4-83ba-72a1829ed798

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-