Radiesse

GUDID 03770034301097

UNIVERDERM

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 03770034301097
• NIH Device Record Key: af48a84a-41d2-4f57-b8e6-3bca6aa0d512
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiesse
• Version Model Number: 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	03770034301097 [Package]; Contains: 03770034301103; Package: [2 Units]; In Commercial Distribution
GS1	03770034301103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050052

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: 2024-12-10
• Device Publish Date: 2024-12-02

Devices Manufactured by UNIVERDERM

• 03770034301158 - Synvisc: 2025-03-21
• 03770034301172 - Synvisc: 2025-03-21
• 03770034301134 - BD: 2025-02-07
• 03770034301097 - Radiesse: 2024-12-10
• 03770034301097 - Radiesse: 2024-12-10
• 03770034301127 - Sculptra: 2024-12-10
• 03770034301110 - Restylane Eyelight: 2024-12-03
• 03770034301004 - Juvederm: 2024-03-05
• 03770034301011 - Juvederm: 2024-03-05