Duns Number:216903276
Catalog Number
-
Brand Name
Synvisc
Version/Model Number
5 Count
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
93c398de-0fe5-42ad-82c7-e774eec05780
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 28, 2016
Package DI Number
5060497630055
Quantity per Package
5
Contains DI Package
05060497630048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 5 |