AART Calf Implant 502-201B

GUDID B490502201B0

Calf Sty 2 Sz 1 Sterile

Aart

Silicone-block tissue reconstructive material

• Primary Device ID: B490502201B0
• NIH Device Record Key: 1f38585a-e097-4c14-817a-b61dfc1def35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Calf Implant
• Version Model Number: B
• Catalog Number: 502-201B
• 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: false
• 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: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B490502201B0 [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

[B490502201B0]

Dry Heat Sterilization

[B490502201B0]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-20

On-Brand Devices [AART Calf Implant]

• B490502309E0: Calf Sty 3 Sz 9 Sterile
• B490502308E0: Calf Sty 3 Sz 8 Sterile
• B490502307E0: Calf Sty 3 Sz 7 Sterile
• B490502306E0: Calf Sty 3 Sz 6 Sterile
• B490502305E0: Calf Sty 3 Sz 5 Sterile
• B490502304E0: Calf Sty 3 Sz 4 Sterile
• B490502303E0: Calf Sty 3 Sz 3 Sterile
• B490502302E0: Calf Sty 3 Sz 2 Sterile
• B490502301E0: Calf Sty 3 Sz 1 Sterile
• B490502300E0: Calf Sty 3 Sz 0 Sterile
• B490502202C0: Calf Sty 2 Sz 2 Sterile
• B490502202B0: Calf Sty 2 Sz 2 Sterile
• B490502201C0: Calf Sty 2 Sz 1 Sterile
• B490502201B0: Calf Sty 2 Sz 1 Sterile
• B490502107A0: Calf Sty1 Sz 7 Sterile
• B490502106B0: Calf Sty 1 Sz 6 Sterile
• B490502106A0: Calf Sty 1 Sz 6 Sterile
• B490502105B0: Calf Sty 1 Sz 5 Sterile
• B490502104C0: Calf Sty 1 Sz 4 Sterile
• B490502104B0: Calf Sty 1 Sz 4 Sterile
• B490502103C0: Calf Sty 1 Sz 3 Sterile
• B490502103B0: Calf Sty1 Sz 3 Sterile
• B490502102C0: Calf Sty1 Sz 2 Sterile
• B490502102B0: Calf Sty1 Sz 2 Sterile
• B490502101C0: Calf Sty 1 Sz 1 Sterile
• B490502101B0: Calf Sty1 Sz 1 Sterile