Restylane

GUDID 07331689111651

Q-Med AB

Dermal tissue reconstructive material, microbe-derived

• Primary Device ID: 07331689111651
• NIH Device Record Key: bea18238-be05-4418-b208-4e91a042588e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restylane
• Version Model Number: Gel 1.0 ml syringe
• Company DUNS: 355371873
• Company Name: Q-Med AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigeration not required
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose to direct sunlight
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331689111651 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040024

FDA Product Code

• LMH: Implant, Dermal, For Aesthetic Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-10-10

On-Brand Devices [Restylane]

• 07331689113709: Gel 1.0 ml syringe
• 07331689111668: Gel 1.0 ml syringe - demo
• 07331689111651: Gel 1.0 ml syringe
• 00302995969134: Gel 1 mL Syringe
• 00302995969141: Gel 1 mL Syringe
• 07331689117035: Gel 1 mL Syringe