Duns Number:196603781
Device Description: IOL TRULIGN TORIC 29.00D X 2.75 CYL
Catalog Number
BL1UT2900275
Brand Name
Trulign IOL
Version/Model Number
BL1UT2900275
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
MJP
Product Code Name
Lens, Intraocular, Toric Optics
Public Device Record Key
f4693c6f-2dc7-4772-9abd-83f4027f3506
Public Version Date
July 08, 2021
Public Version Number
3
DI Record Publish Date
September 16, 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 |