Catalog Number

506005078078

Brand Name

Actifuse Flow

Version/Model Number

506005078078

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

K181306,K181306

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Public Device Record Key

9bfbe4a8-1c0e-4eac-92b6-56a79d9a68fd

Public Version Date

October 11, 2022

Public Version Number

3

DI Record Publish Date

October 10, 2018

Package DI Number

55060050780789

Quantity per Package

1

Contains DI Package

05060050780784

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE