Duns Number:807613393
Device Description: 0.8 mL, 12 mg/mL Sodium Hyaluronate
Catalog Number
-
Brand Name
Optivisc
Version/Model Number
600-105
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
P000046
Product Code
LZP
Product Code Name
Aid, Surgical, Viscoelastic
Public Device Record Key
cfe035b4-1754-4e0e-888c-f48f8b343c8e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 15, 2014
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| 3 | A medical device with high risk that requires premarket approval | 15 |