Catalog Number

BS-1521

Brand Name

Straumann® cerabone®

Version/Model Number

BS-1521

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

NPM

Product Code Name

Bone Grafting Material, Animal Source

Public Device Record Key

f24eed14-cace-4f9e-90a7-8609215d69d5

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-