Duns Number:103021940
Device Description: 21 GA LAMINAR PHACO TIP 45D SL REUSABLE
Catalog Number
OPOR4521R
Brand Name
LAMINAR
Version/Model Number
OPOR4521R
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
-
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
HQC
Product Code Name
Unit, phacofragmentation
Public Device Record Key
cef8e897-99b3-48d6-af7e-edd0c344d92a
Public Version Date
February 26, 2020
Public Version Number
4
DI Record Publish Date
June 05, 2017
Package DI Number
35050474573308
Quantity per Package
6
Contains DI Package
05050474573307
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 3950 |