Catalog Number

RESFIL1114C1DTB

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

037c4d09-7af4-4d56-8aed-2c7f26bad52a

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

08033860024567

Quantity per Package

10

Contains DI Package

08033860024550

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

POUCH