Catalog Number

165.02SI

Brand Name

PRODONT-HOLLIGER

Version/Model Number

165.02SI

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

EKC

Product Code Name

Excavator, Dental, Operative

Public Device Record Key

6fcac0f7-21c2-4a6a-94ad-8b59ac4ec40a

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-