Duns Number:103021940
Device Description: ACUVUE REVITALENS MPDS SC 60ML+LC
Catalog Number
94311HZ
Brand Name
ACUVUE REVITALENS MPDS
Version/Model Number
94311HZ
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)
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
d98ff10b-b377-4c5a-8e71-6339a22de636
Public Version Date
February 26, 2020
Public Version Number
2
DI Record Publish Date
July 15, 2019
Package DI Number
30827444001643
Quantity per Package
24
Contains DI Package
00827444001642
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 | 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 |