Restylane Eyelight

GUDID 03770034301110

UNIVERDERM

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID03770034301110
NIH Device Record Key0abe8e28-8a81-49a4-b1a1-a046cc440772
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestylane Eyelight
Version Model NumberInjectable Gel
Company DUNS281488639
Company NameUNIVERDERM
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103770034301110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LMHImplant, Dermal, For Aesthetic Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-03
Device Publish Date2024-11-25

Devices Manufactured by UNIVERDERM

03770034301097 - Radiesse2024-12-10
03770034301127 - Sculptra2024-12-10
03770034301110 - Restylane Eyelight 2024-12-03
03770034301110 - Restylane Eyelight 2024-12-03
03770034301004 - Juvederm2024-03-05
03770034301011 - Juvederm2024-03-05
03770034301028 - Restylane2024-03-05
03770034301035 - Restylane2024-03-05
03770034301042 - Restylane2024-03-05

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