Catalog Number

-

Brand Name

Bio2 Technologies

Version/Model Number

1000035

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

K142463,K152589

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

e469865d-0403-4f2e-bee3-b0ac4bebd564

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-