Catalog Number

861-201

Brand Name

Supplies

Version/Model Number

861-201

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 24, 2022

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

-

Product Code

EGD

Product Code Name

WAX, DENTAL, INTRAORAL

Public Device Record Key

1a55496e-a408-4456-aacc-cb9368b09b9c

Public Version Date

April 25, 2022

Public Version Number

2

DI Record Publish Date

April 05, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-