Catalog Number

BPY-001

Brand Name

BioSphere Putty

Version/Model Number

1cc

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

K140844

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

db415542-ed1a-4062-b42e-da66d130c6e9

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

February 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-