Catalog Number

-

Brand Name

CONFIRM

Version/Model Number

8114.0110S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133678

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Public Device Record Key

54761eaa-ef60-4cdc-aded-b82da4456092

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-