Catalog Number

01-040

Brand Name

J & J INSTRUMENTS

Version/Model Number

01-040

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

EKI

Product Code Name

Carrier, Amalgam, Operative

Public Device Record Key

120af3a1-2bab-41aa-8a20-737a6c9b57ad

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-