Duns Number:103021940
Device Description: PACK, COMPACT INTUITIV, MULTIPLE-USE
Catalog Number
OPO85
Brand Name
COMPACT INTUITIV
Version/Model Number
OPO85
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
8838758d-6604-4b49-8921-963d1f8c9550
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
September 02, 2016
Package DI Number
25050474573363
Quantity per Package
6
Contains DI Package
05050474573369
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 |