Catalog Number

-

Brand Name

SPY PAQ®

Version/Model Number

SK6000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 18, 2020

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

-

Product Code Name

-

Public Device Record Key

24268f7d-8177-4914-8f25-a9e2bd59e1ec

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

20858901006218

Quantity per Package

6

Contains DI Package

10858901006211

Package Discontinue Date

September 18, 2020

Package Status

Not in Commercial Distribution

Package Type

PAQ