Duns Number:803926252
Device Description: POSTERIOR CHAMBER INTRAOCULAR LENS
Catalog Number
-
Brand Name
ISOTECHNICS
Version/Model Number
UCN5-B-21.5
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
P880072
Product Code
HQL
Product Code Name
Intraocular Lens
Public Device Record Key
62dec79f-860e-4398-a9bd-58836ee83662
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
September 18, 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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 7527 |