AART Gluteal Implant Sizer 501-201-2C

GUDID B4905012012C0

Szr - Gluteal Sty 2 Sz 1 NS

Aart

Silicone-block tissue reconstructive material

• Primary Device ID: B4905012012C0
• NIH Device Record Key: ead9308c-38aa-4ffc-841e-320f9376461e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Gluteal Implant Sizer
• Version Model Number: C
• Catalog Number: 501-201-2C
• 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	B4905012012C0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021839

FDA Product Code

• MIB: ELASTOMER, SILICONE BLOCK

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

On-Brand Devices [AART Gluteal Implant Sizer]

• B4905016042B0: Szr - Gluteal Sty 6 Sz 4 NS
• B4905016042A0: Szr - Gluteal Sty 6 Sz 4 NS
• B4905016032C0: Szr - Gluteal Sty 6 Sz 3 NS
• B4905016022C0: Szr - Gluteal Sty 6 Sz 2 NS
• B4905016012C0: Szr - Gluteal Sty 6 Sz 1 NS
• B4905013102A0: Szr - Gluteal Sty 3 Sz10 NS
• B4905013092A0: Szr - Gluteal Sty 3 Sz 9 NS
• B4905013082B0: Szr - Gluteal Sty 3 Sz 8 NS
• B4905013072C0: Szr - Gluteal Sty 3 Sz 7 NS
• B4905013062C0: Szr - Gluteal Sty 3 Sz 6 NS
• B4905013052C0: Szr - Gluteal Sty 3 Sz 5 NS
• B4905013042C0: Szr - Gluteal Sty 3 Sz 4 NS
• B4905013032C0: Szr - Gluteal Sty 3 Sz 3 NS
• B4905013022C0: Szr - Gluteal Sty 3 Sz 2 NS
• B4905013012C0: Szr - Gluteal Sty 3 Sz 1 NS
• B4905013002C0: Szr - Gluteal Sty 3 Sz 0 NS
• B4905012062C0: Szr - Gluteal Sty 2 Sz 6 NS
• B4905012052C0: Szr - Gluteal Sty 2 Sz 5,NS
• B4905012042C0: Szr - Gluteal Sty 2 Sz 4 NS
• B4905012032C0: Szr - Gluteal Sty 2 Sz 3 NS
• B4905012022C0: Szr - Gluteal Sty 2 Sz 2 NS
• B4905012012C0: Szr - Gluteal Sty 2 Sz 1 NS
• B4905011062C0: Szr - Gluteal Sty 1 Sz 6 NS
• B4905011061A0: Szr - Gluteal Sty 1 Sz 6 Sterile
• B4905011052C0: Szr - Gluteal Sty 1 Sz 5 NS
• B4905011051A0: Szr - Gluteal Sty 1 Sz 5 Sterile
• B4905011042C0: Szr - Gluteal Sty 1 Sz 4 NS
• B4905011042B0: Szr - Gluteal Sty 1 Sz 4 NS
• B4905011032C0: Szr - Gluteal Sty 1 Sz 3 NS
• B4905011022C0: Szr - Gluteal Sty 1 Sz 2 NS
• B4905011012C0: Szr - Gluteal Sty 1 Sz 1 NS
• B4905011012B0: Szr - Gluteal Sty 1 Sz 1 NS