Duns Number:894831895
Device Description: Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automati Foldable, posterior chamber intraocular lens (IOL), preloaded in an injector that automatically folds the lens as it is advanced, prior to insertion. Single use.
Catalog Number
-
Brand Name
IPure
Version/Model Number
B3PC (clear), +11.50D
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
8eed3c3c-ec1b-4a82-b20e-a35e0d5c22a2
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
May 19, 2020
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 | 622 |