Catalog Number

-

Brand Name

NCB®

Version/Model Number

47-2232-060-01

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

K120772

Product Code

HRS

Product Code Name

Plate, fixation, bone

Public Device Record Key

8eb8ff82-4c30-4700-bfcb-9c41e7c02801

Public Version Date

October 14, 2019

Public Version Number

3

DI Record Publish Date

October 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-