Duns Number:355371873
Catalog Number
-
Brand Name
Restylane Lyft
Version/Model Number
Gel 1 mL Syringe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P040024
Product Code
LMH
Product Code Name
Implant, Dermal, For Aesthetic Use
Public Device Record Key
ff0be08a-0c13-4e75-b59c-56238cca0893
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 11, 2015
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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 35 |