Restylane-L

GUDID 07331689113822

Q-Med AB

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07331689113822
NIH Device Record Key6c9be830-00b3-4ad2-a50f-a7ba3c4a1107
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestylane-L
Version Model NumberGel 1.0 ml syringe - demo
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
GS107331689113822 [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-L]

07331689113822Gel 1.0 ml syringe - demo
07331689113815Gel 1.0 ml syringe
07331689113792Gel 0.5 ml syringe
07331689111774Gel 2.0 ml syringe - demo
07331689111767Gel 2.0 ml syringe
07331689111750Gel 1.0 ml syringe - demo
07331689111743Gel 1.0 ml syringe
07331689111736Gel 0.5 ml syringe
00302995967161Gel 1.0 ml syringe - demo
00302995967154Gel 1 mL Syringe
00302995967147Gel 1.0 ml syringe - demo
00302995967079Gel 1 mL Syringe
07331689117134Gel 1 mL Syringe
07331689117042Gel 1.0 ml syringe - Demo

Trademark Results [Restylane-L]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RESTYLANE-L
RESTYLANE-L
77940127 3845222 Dead/Cancelled
NESTLÉ SKIN HEALTH S.A.
2010-02-19

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