Catalog Number

BSF-00075

Brand Name

BioSphere Flex SP

Version/Model Number

Medium

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

K173424

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Public Device Record Key

92d82eda-3be1-4b09-81fa-e6ab584d5fb7

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-