Catalog Number

01-450

Brand Name

J & J INSTRUMENTS

Version/Model Number

01-450

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

EIK

Product Code Name

Carver, Wax, Dental

Public Device Record Key

70dc6d81-d0fd-4941-8360-29866fb2189c

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

May 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-