Catalog Number

-

Brand Name

Orthofuser

Version/Model Number

Orthofuser

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

K912019,K912019

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Public Device Record Key

05fc074b-f869-45d7-83cb-28285458cab7

Public Version Date

January 08, 2021

Public Version Number

5

DI Record Publish Date

March 10, 2016

Package DI Number

10803622130806

Quantity per Package

12

Contains DI Package

00803622130809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE