Duns Number:243730939
Device Description: SPY-PHI Kit
Catalog Number
-
Brand Name
SPY-PHI System
Version/Model Number
HH9001
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
f8ca0c26-c8f2-4cff-abed-d08846411aee
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
March 31, 2017
Package DI Number
20858701006289
Quantity per Package
6
Contains DI Package
10858701006282
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |
| 3 | A medical device with high risk that requires premarket approval | 1 |