Restylane Lyft - Q-Med AB

Duns Number:355371873

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More Product Details

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

Product Characteristics

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 Details

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"Q-MED AB" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 35