Calf Implant 502-105

GUDID B490502105

Calf Style 1 Size 5

Aart

Silicone-block tissue reconstructive material

• Primary Device ID: B490502105
• NIH Device Record Key: ec6f7a72-ecf6-4a6f-8746-b9761ad61ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calf Implant
• Version Model Number: E
• Catalog Number: 502-105
• Company DUNS: 091356894
• Company Name: Aart
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com
• Phone: (775) 853-6800
• Email: customer.service@alphaaesthetics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B490502105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022511

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

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

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

[B490502105]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-10
• Device Publish Date: 2025-09-02

On-Brand Devices [Calf Implant]

• B490502309: Calf Style 3 Size 9
• B490502308: Calf Style 3 Size 8
• B490502307: Calf Style 3 Size 7
• B490502306: Calf Style 3 Size 6
• B490502305: Calf Style 3 Size 5
• B490502304: Calf Style 3 Size 4
• B490502303: Calf Style 3 Size 3
• B490502302: Calf Style 3 Size 2
• B490502301: Calf Style 3 Size 1
• B490502300: Calf Style 3 Size 0
• B490502202: Calf Style 2 Size 2
• B490502201: Calf Style 2 Size 1
• B490502107: Calf Style 1 Size 7
• B490502106: Calf Style 1 Size 6
• B490502105: Calf Style 1 Size 5
• B490502104: Calf Style 1 Size 4
• B490502103: Calf Style 1 Size 3
• B490502102: Calf Style 1 Size 2
• B490502101: Calf Style 1 Size 1