Catalog Number

01-300

Brand Name

J & J INSTRUMENTS

Version/Model Number

01-300

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 31, 2018

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

b5cc0894-7373-4521-aaaa-7b5895c9832c

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

May 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-