Duns Number:103021940
Device Description: ULTRAZYME ENZYMATIC CLEANER 20 TABLETS
Catalog Number
90278
Brand Name
ULTRAZYME
Version/Model Number
90278
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LPN
Product Code Name
Accessories, soft lens products
Public Device Record Key
b608731e-7787-4212-9ff4-622d5b1b6faf
Public Version Date
February 26, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
20827444000151
Quantity per Package
6
Contains DI Package
00827444000157
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 3950 |