Restylane Lyft - ACRE PHARMA LIMITED

Duns Number:218668297

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More Product Details

Catalog Number

-

Brand Name

Restylane Lyft

Version/Model Number

N/A

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LMH

Product Code Name

Implant, Dermal, For Aesthetic Use

Device Record Status

Public Device Record Key

d62699b7-972e-4d0a-88f2-8022e7290852

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACRE PHARMA LIMITED" Characteristics
Device Class Device Class Description No of Devices
3 A medical device with high risk that requires premarket approval 9