Catalog Number

AK-01500

Brand Name

ARROW

Version/Model Number

IPN033839

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K904021,K904021

Product Code

JDC

Product Code Name

PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Public Device Record Key

7e4e681b-cab9-4516-b7bf-f915f4b71b03

Public Version Date

January 31, 2020

Public Version Number

2

DI Record Publish Date

June 11, 2018

Package DI Number

40801902004800

Quantity per Package

5

Contains DI Package

50801902004807

Package Discontinue Date

January 30, 2020

Package Status

Not in Commercial Distribution

Package Type

Case