Restylane Lyft with Lidocaine

GUDID 07331689117141

Q-Med AB

Dermal tissue reconstructive material, microbe-derived, anaesthetic
Primary Device ID07331689117141
NIH Device Record Key56f774ca-9b97-41e0-827e-55e1e3f63f0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRestylane Lyft with Lidocaine
Version Model NumberGel 1 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 Producttrue
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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107331689117141 [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 Date2024-05-13
Device Publish Date2024-05-03

On-Brand Devices [Restylane Lyft with Lidocaine]

07331689114027Gel 1 mL - Demo
07331689114010Gel 1 mL Syringe
00302995963262Gel 1.0 ml syringe - demo
00302995963255Gel 1 mL Syringe
00302995963248Gel 1.0 ml syringe - demo
07331689117141Gel 1 mL Syringe
07331689117066Gel 1.0 ml syringe - Demo

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