Catalog Number

ASK-04000-WA

Brand Name

ARROW

Version/Model Number

IPN034200

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"

Yes

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

K904021,K904021

Product Code

JDC

Product Code Name

PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Public Device Record Key

467fd599-bb30-4dc8-8025-0b05c6a69ec4

Public Version Date

June 04, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

30801902071737

Quantity per Package

5

Contains DI Package

00801902071736

Package Discontinue Date

June 03, 2021

Package Status

Not in Commercial Distribution

Package Type

Case