Catalog Number

N162530-1

Brand Name

creos™ syntoprotect

Version/Model Number

N162530-1

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

-

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

af7f51f9-8d26-4ab2-9e38-529fe4f79f16

Public Version Date

January 21, 2021

Public Version Number

1

DI Record Publish Date

January 13, 2021

Package DI Number

17332747181859

Quantity per Package

4

Contains DI Package

07332747181852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box