Duns Number:006309355
Device Description: HealthSonics Multi-Purpose Ultrasonic Cleaning Solution, 1 Gallon x 4ct
Catalog Number
350-060
Brand Name
Health Sonics
Version/Model Number
350-060
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
-
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
FLG
Product Code Name
Cleaner, ultrasonic, medical instrument
Public Device Record Key
cee35051-4339-4189-9398-788bf81f4c03
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
20302733500609
Quantity per Package
1
Contains DI Package
00302733500605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |