Duns Number:008018525
Device Description: 27+* TOTALPLUS* Combined Procedure Pak Beveled 10,000 CPM ULTRAVIT* Probe Straight Endo 0. 27+* TOTALPLUS* Combined Procedure Pak Beveled 10,000 CPM ULTRAVIT* Probe Straight Endo 0.9 Tipless Anterior Kit
Catalog Number
-
Brand Name
Constellation, ULTRAVIT, EdgePlus, TotalPlus
Version/Model Number
8065752452
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
107cff3d-bd63-49e8-b492-97f07d747893
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 29, 2017
Package DI Number
10380657524522
Quantity per Package
6
Contains DI Package
00380657524525
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 |