Duns Number:103021940
Device Description: PKG ASSY, OPOS21LD 21GA IRRIGATION
Catalog Number
OPOS21LD
Brand Name
LAMINAR
Version/Model Number
OPOS21LD
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
HQC
Product Code Name
Unit, phacofragmentation
Public Device Record Key
a7c61055-fb01-47a2-a410-69459fbe98c7
Public Version Date
February 26, 2020
Public Version Number
8
DI Record Publish Date
September 02, 2016
Package DI Number
15050474547077
Quantity per Package
6
Contains DI Package
05050474547070
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 |