Duns Number:008018525
Device Description: AcrySof(R) Natural MULTIPIECE ACRYLIC FOLDABLEIOL W/BLUE LIGHT FILTER PCL(IOL/PC) 13.0mmLE AcrySof(R) Natural MULTIPIECE ACRYLIC FOLDABLEIOL W/BLUE LIGHT FILTER PCL(IOL/PC) 13.0mmLENGTH 6.0mm MENISCUS OPTIC 5-DEGREEMonoflex(TM*) HAPTICS.*REG. US PAT. & TM OFF
Catalog Number
MN60MA.010
Brand Name
ACRYSOF®Monoflex®
Version/Model Number
MN60MA
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HQL
Product Code Name
intraocular lens
Public Device Record Key
7c6a90db-e526-45f1-bae5-4588b82e3c5d
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |