Catalog Number

-

Brand Name

BioBall™

Version/Model Number

HM39106

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 13, 2021

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

-

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

FZX

Product Code Name

Guide, surgical, instrument

Public Device Record Key

f12855dd-37b1-46be-a922-4fc47b4477a7

Public Version Date

December 14, 2021

Public Version Number

2

DI Record Publish Date

November 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-