Radiesse

GUDID 05060457760082

LAMBSMEAD LTD

Dermal tissue reconstructive material, animal-derived

• Primary Device ID: 05060457760082
• NIH Device Record Key: c3f1924b-6002-4e3a-9450-54b7ab5412ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Radiesse
• Version Model Number: 8071M5K1
• Company DUNS: 235542735
• Company Name: LAMBSMEAD LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060457760082 [Primary]

FDA Product Code

• MIX: System, Vocal Cord Medialization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-24

Devices Manufactured by LAMBSMEAD LTD

• 05060457760006 - Juvederm Volbella: 2018-03-29
• 05060457760013 - Juvederm Volift: 2018-03-29
• 05060457760020 - Juvederm Voluma: 2018-03-29
• 05060457760037 - Juvederm Ultra 4: 2018-03-29
• 05060457760044 - Juvederm Ultra Smile: 2018-03-29
• 05060457760051 - Juvederm Ultra 3: 2018-03-29
• 05060457760068 - Juvederm Ultra 2: 2018-03-29
• 05060457760075 - Juvederm Hydrate: 2018-03-29