Catalog Number

0909-400-500

Brand Name

SpineJack

Version/Model Number

0909400500

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

Yes

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

KIH

Product Code Name

DISPENSER, CEMENT

Public Device Record Key

bdc01cb3-0849-45ab-92a5-88dcb0218982

Public Version Date

August 04, 2020

Public Version Number

1

DI Record Publish Date

July 27, 2020

Package DI Number

33760253800533

Quantity per Package

6

Contains DI Package

03760253800532

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack