Catalog Number

0306131000

Brand Name

NA

Version/Model Number

0306131000

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

OAR

Product Code Name

Injector, vertebroplasty (does not contain cement)

Public Device Record Key

f829da40-6813-4b6f-9b01-0d677b80c9f7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

34546540434310

Quantity per Package

6

Contains DI Package

04546540434319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack