Restylane

GUDID 03770034301042

UNIVERDERM

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 03770034301042
• NIH Device Record Key: 6e84ee11-001f-4e88-b4e0-0976cb7f7d80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restylane
• Version Model Number: Kysse with Lidocaine
• Company DUNS: 281488639
• Company Name: UNIVERDERM
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770034301042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P140029

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: 2024-03-05
• Device Publish Date: 2024-02-26

On-Brand Devices [Restylane]

• 03770034301066: Lidocaine
• 03770034301059: Defyne with Lidocaine
• 03770034301042: Kysse with Lidocaine
• 03770034301035: Lyft Lidocaine
• 03770034301028: Refyne with Lidocaine