Catalog Number

925.SAS-WS-BX10

Brand Name

Bone Foam

Version/Model Number

925.SAS-WS-BX10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Public Device Record Key

7d778fc5-ecef-43b1-afa2-69b719bdc96e

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-