Catalog Number

-

Brand Name

ZOLL-DENTAL

Version/Model Number

OPHAT-17/18

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

EKD

Product Code Name

INSTRUMENT, CUTTING, OPERATIVE

Public Device Record Key

111adc9a-c4a2-4dd0-af25-1884bded4d6f

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

March 10, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-