Restylane

GUDID 07331689113709

Q-Med AB

Dermal tissue reconstructive material, microbe-derived
Primary Device ID07331689113709
NIH Device Record Keyaf0b975e-f5f4-4dff-b689-88cba01d7095
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestylane
Version Model NumberGel 1.0 ml syringe
Company DUNS355371873
Company NameQ-Med AB
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not expose to direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Refrigeration not required

Device Identifiers

Device Issuing AgencyDevice ID
GS107331689113709 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-13

On-Brand Devices [Restylane]

07331689113709Gel 1.0 ml syringe
07331689111668Gel 1.0 ml syringe - demo
07331689111651Gel 1.0 ml syringe
00302995969134Gel 1 mL Syringe
00302995969141Gel 1 mL Syringe

Trademark Results [Restylane]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTYLANE
RESTYLANE
90382900 not registered Live/Pending
Galderma Holding S.A.
2020-12-15
RESTYLANE
RESTYLANE
87910214 5632750 Live/Registered
Nestlé Skin Health S.A.
2018-05-07
RESTYLANE
RESTYLANE
87392183 5301598 Live/Registered
Nestlé Skin Health S.A.
2017-03-30
RESTYLANE
RESTYLANE
77117631 3293479 Dead/Cancelled
NESTLÉ SKIN HEALTH S.A.
2007-02-27
RESTYLANE
RESTYLANE
75397541 2390731 Live/Registered
NESTLÉ SKIN HEALTH S.A.
1997-12-01
RESTYLANE
RESTYLANE
74622267 2030837 Dead/Cancelled
HA NORTH AMERICAN SALES AB
1995-01-17

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