Catalog Number

QO.243.06

Brand Name

Quinelato

Version/Model Number

QO.243.06

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KDG

Product Code Name

Chisel (Osteotome)

Public Device Record Key

883e36be-e819-4b7b-8a92-cd7ae13994d2

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-