Catalog Number

1666-01/C

Brand Name

StabiliT®

Version/Model Number

00884450379844

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072496,K072496

Product Code

NDN

Product Code Name

CEMENT, BONE, VERTEBROPLASTY

Public Device Record Key

37be9fc4-7e76-486c-a661-f528c8e559e2

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Package DI Number

10884450379841

Quantity per Package

1

Contains DI Package

00884450379844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-