Sculptra

GUDID 07331689116106

Q-Med AB

Dermal tissue reconstructive material, synthetic mineral

• Primary Device ID: 07331689116106
• NIH Device Record Key: 2a7478ed-3378-424a-bef9-c49f73a1710a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sculptra
• Version Model Number: 2 vial pack
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Freeze
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature up to 30°C (86°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	07331689116106 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-07
• Device Publish Date: 2024-04-29

On-Brand Devices [Sculptra ]

• 07331689116106: 2 vial pack
• 07331689116113: 1 vial pack-Sample