AART Malar Implant 401-101-5B

GUDID B4904011015B0

Malar Sty 1 Sz 1 L Sterile

Aart

Malar prosthesis

• Primary Device ID: B4904011015B0
• NIH Device Record Key: 03a1aca1-c5fe-40a2-99e3-3c0859def1fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Malar Implant
• Version Model Number: B
• Catalog Number: 401-101-5B
• 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	B4904011015B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021419

FDA Product Code

• LZK: IMPLANT, MALAR

Sterilization

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

[B4904011015B0]

Dry Heat Sterilization

[B4904011015B0]

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 Malar Implant]

• B490401202A0: Malar Sty 2 Sz 2 L&R Sterile
• B4904012026B0: Malar Sty 2 Sz 2 R Sterile
• B4904012026A0: Malar Sty 2 Sz 2 R Sterile
• B4904012025B0: Malar Sty 2 Sz 2 L Sterile
• B4904012025A0: Malar Sty 2 Sz 2 L Sterile
• B490401201A0: Malar Sty 1 Sz 2 L&R Sterile
• B4904012016B0: Malar Sty 2 Sz 1 R Sterile
• B4904012016A0: Malar Sty 2 Sz 1 R Sterile
• B4904012015B0: Malar Sty 2 Sz 1 L Sterile
• B4904012015A0: Malar Sty 2 Sz 1 L Sterile
• B490401103A0: Malar Sty 1 Sz 3 L &.R Sterile
• B4904011036B0: Malar Sty 1 Sz 3 R Sterile
• B4904011036A0: Malar Sty 1 Sz 3 R Sterile
• B4904011035B0: Malar Sty 1 Sz 3 L Sterile
• B4904011035A0: Malar Sty 1 Sz 3 L Sterile
• B490401102A0: Malar Sty 1 Sz 2 L&R Sterile
• B4904011026B0: Malar Sty 1 Sz 2 R Sterile
• B4904011026A0: Malar Sty 1 Sz 2 R Sterile
• B4904011025B0: Malar Sty 1 Sz 2 L Sterile
• B4904011025A0: Malar Sty 1 Sz 2 L Sterile
• B490401101A0: Malar Sty 1 Sz 1 L&R Sterile
• B4904011016B0: Malar Sty 1 Sz 1 R Sterile
• B4904011016A0: Malar Sty 1 Sz 1 R Sterile
• B4904011015B0: Malar Sty 1 Sz 1 L Sterile
• B4904011015A0: Malar Sty 1 Sz 1 L Sterile