Duns Number:067486548
Device Description: PI SPRAY II Ultrasound Cleaning Solution:250 ml spray bottle
Catalog Number
36-2103-25
Brand Name
Pharmaceutical Innovations
Version/Model Number
PI SPRAY II Cleaning Solution
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
LRJ
Product Code Name
Disinfectant, Medical Devices
Public Device Record Key
6cd0a2bf-d9dd-4e42-890a-e47ce06e98e5
Public Version Date
March 19, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10300362103256
Quantity per Package
12
Contains DI Package
00300362103259
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |