Catalog Number

0306511000

Brand Name

VertePort

Version/Model Number

0306511000

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

b1809f16-4f3b-4cd3-9b68-0971ae0771df

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Package DI Number

37613252594308

Quantity per Package

18

Contains DI Package

07613252594307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack