Duns Number:008018525
Device Description: 23 GA TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endo 23 GA TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Wide Angle Endoilluminator 0.9 mm Tipless Anterior Kit
Catalog Number
-
Brand Name
Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT
Version/Model Number
8065752449
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
MLZ
Product Code Name
Vitrectomy, instrument cutter
Public Device Record Key
978c9a3f-1f74-48a5-8188-e2659f7f6da5
Public Version Date
January 24, 2022
Public Version Number
2
DI Record Publish Date
July 19, 2018
Package DI Number
10380657524492
Quantity per Package
6
Contains DI Package
00380657524495
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 |