AART Marlar Implant Sizer 401-101-6-2A

GUDID B49040110162A0

Szr - Malar Sty 1 Sz 1 R NS

Aart

Malar prosthesis

• Primary Device ID: B49040110162A0
• NIH Device Record Key: 27a099aa-2ed0-436e-88eb-c4436b9780b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Marlar Implant Sizer
• Version Model Number: A
• Catalog Number: 401-101-6-2A
• 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	B49040110162A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021419

FDA Product Code

• LZK: IMPLANT, MALAR

Sterilization

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

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

Devices Manufactured by Aart

• B4902001205A0 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting,12"x12"x.005 NR Sterile
• B4902003305B1 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 3"x3"x.005 NR Sterile
• B4902003310B1 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 3"x3"x.010 NR Sterile
• B4902003320B1 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 3"x3"x.020 NR Sterile
• B4902003330A1 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 3"x3"x.030 NR Sterile
• B4902003340A1 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 3"x3"x.040 NR Sterile
• B49020066058A0 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 6"x6"x.005 NR NS
• B4902006605A0 - AART Silicone Sheeting: 2018-07-06 Silicone Sheeting, 6"x6"x.005 NR Sterile