Catalog Number

-

Brand Name

SPY-PHI System

Version/Model Number

HH2000

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

-

Product Code Name

-

Public Device Record Key

fd5dacea-f85c-42a4-add2-92a125a82153

Public Version Date

September 10, 2018

Public Version Number

3

DI Record Publish Date

March 31, 2017

Package DI Number

20858701006326

Quantity per Package

20

Contains DI Package

10858701006329

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box