Duns Number:008018525
Device Description: CENTURION® Vision System Gravity FMS w/ INTREPID® Ultra Sleeves 0.9MM 45° ABS* INTREPID Hy CENTURION® Vision System Gravity FMS w/ INTREPID® Ultra Sleeves 0.9MM 45° ABS* INTREPID Hybrid Tip
Catalog Number
-
Brand Name
CENTURION®, INTREPID®
Version/Model Number
8065753143
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
751847f3-1f6a-4ace-8c89-cc4570a8a273
Public Version Date
January 24, 2022
Public Version Number
2
DI Record Publish Date
November 22, 2019
Package DI Number
10380657531438
Quantity per Package
6
Contains DI Package
00380657531431
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 250 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 541 |
| 3 | A medical device with high risk that requires premarket approval | 6098 |