Catalog Number

-

Brand Name

ZOLL-DENTAL

Version/Model Number

OPCS-DE

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

GAF

Product Code Name

SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

ffb8d116-d92f-499f-948c-6d87166c3730

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-