Duns Number:807613393
Device Description: Crosslinked Sodium Hyaluronate 22 mg/mL
Catalog Number
-
Brand Name
Monovisc
Version/Model Number
690016
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
MOZ
Product Code Name
Acid, Hyaluronic, Intraarticular
Public Device Record Key
ae0edbd2-9ceb-4f2f-80f4-5ca5264f5d2d
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 07, 2021
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 |