Catalog Number

925.GULLYDRB

Brand Name

Bone Foam, Inc

Version/Model Number

925.GULLYDRB

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 13, 2019

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

232e2a42-cca6-4041-bfb6-ec5c0e595fc7

Public Version Date

April 07, 2022

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

B197925GULLYDRB1

Quantity per Package

12

Contains DI Package

B197925GULLYDRB0

Package Discontinue Date

September 13, 2019

Package Status

Not in Commercial Distribution

Package Type

-