Catalog Number

925.TRPPSB

Brand Name

Bone Foam, Inc.

Version/Model Number

925.TRPPSB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2018

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"

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

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

c4c06e0c-29d8-447b-abd5-c453956f1bc6

Public Version Date

April 06, 2022

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

B197925TRPPSB1

Quantity per Package

20

Contains DI Package

B197925TRPPSB0

Package Discontinue Date

November 01, 2018

Package Status

Not in Commercial Distribution

Package Type

-