Catalog Number

03-191

Brand Name

J & J INSTRUMENTS INC

Version/Model Number

03-191

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

2a3bcf43-9ac4-4a21-8038-cafc85ab5c50

Public Version Date

November 19, 2018

Public Version Number

1

DI Record Publish Date

October 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-