Duns Number:196603781
Device Description: LI61AO 13.00MM 10.50
Catalog Number
LI61AOR1050
Brand Name
SofPort LI61AO
Version/Model Number
LI61AOR1050
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
d6396a3e-e8a6-47ba-8495-ff1dcdb68d16
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
September 17, 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 | 77 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 134 |
| 3 | A medical device with high risk that requires premarket approval | 3348 |
| U | Unclassified | 1 |