Catalog Number

RESFIL1112C1-US

Brand Name

BIOPSYBELL

Version/Model Number

RENOVA SPINE BONE FILLER

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"

Yes

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

98c53c7e-8573-470c-b70c-0cb438ccc123

Public Version Date

June 22, 2020

Public Version Number

1

DI Record Publish Date

June 12, 2020

Package DI Number

08033860034825

Quantity per Package

10

Contains DI Package

08033860034818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BLISTER