Catalog Number

BS-4BS1S

Brand Name

4BONE BCH

Version/Model Number

BS-4BS1S

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"

-

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

K051885

Product Code

LYC

Product Code Name

Bone Grafting Material, Synthetic

Public Device Record Key

f00e1190-ed62-445c-9d8f-efdedab1dfe2

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

May 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-