Catalog Number

5MPSW-145/B

Brand Name

Performa®

Version/Model Number

00884450306826

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

-

Product Code

OJV

Product Code Name

Single use instrument tray

Public Device Record Key

a858e8e7-a7c0-4b10-902d-b3f6c746c6a9

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 13, 2018

Package DI Number

10884450306823

Quantity per Package

5

Contains DI Package

00884450306826

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-