Catalog Number

-

Brand Name

AngioSystems Tray

Version/Model Number

KM5021

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

K905462,K905462

Product Code

LRP

Product Code Name

Tray, Surgical

Public Device Record Key

6a477476-caf0-4fe4-a02b-0aaaddbc9d96

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

September 03, 2018

Package DI Number

00816611024126

Quantity per Package

20

Contains DI Package

00816611024119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-