Catalog Number

-

Brand Name

VCF-000

Version/Model Number

G80000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

OAR

Product Code Name

Injector, Vertebroplasty (Does Not Contain Cement)

Public Device Record Key

2f6b209b-3dd2-4a4a-9fee-df9ddb997093

Public Version Date

May 24, 2021

Public Version Number

1

DI Record Publish Date

May 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-