Catalog Number

104.SLPS-LB

Brand Name

Bone Foam

Version/Model Number

104.SLPS-LB

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

-

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

HST

Product Code Name

Apparatus, traction, non-powered

Public Device Record Key

fec44dd8-4ac1-4d35-b532-9e2036a91264

Public Version Date

May 30, 2022

Public Version Number

1

DI Record Publish Date

May 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-