Catalog Number

32600

Brand Name

BIOPSYBELL

Version/Model Number

V-STRUT 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)

-

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

ce45b3ec-4559-4ca5-b9f5-2ec880563054

Public Version Date

December 30, 2021

Public Version Number

1

DI Record Publish Date

December 22, 2021

Package DI Number

08033860039509

Quantity per Package

10

Contains DI Package

08033860039493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BLISTER