Radiesse

GUDID 08052570473434

DAMBO SRL

Dermal tissue reconstructive material, microbe-derived, anaesthetic

• Primary Device ID: 08052570473434
• NIH Device Record Key: 8af63a3d-6535-49a0-9e24-97faff618204
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiesse
• Version Model Number: NA
• Company DUNS: 440753396
• Company Name: DAMBO SRL
• 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: true
• Manufacturing Date: true
• 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	08052570473434 [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: 2025-10-03
• Device Publish Date: 2025-09-25

Devices Manufactured by DAMBO SRL

• 08052570473212 - Durolane: 2025-10-03
• 08052570473229 - Monovisc: 2025-10-03
• 08052570473434 - Radiesse: 2025-10-03
• 08052570473434 - Radiesse: 2025-10-03
• 08052570477654 - Euflexxa: 2025-10-03