AART Gluteal Implant 501-309A

GUDID B490501309A0

Gluteal Sty 3 Sz 9 Sterile

Aart

Silicone-block tissue reconstructive material

• Primary Device ID: B490501309A0
• NIH Device Record Key: 32fc5aba-2ad0-448d-8ad4-1eca92374a5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Gluteal Implant
• Version Model Number: A
• Catalog Number: 501-309A
• 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
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• 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	B490501309A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021839

FDA Product Code

• MIB: ELASTOMER, SILICONE BLOCK

Sterilization

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

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

Dry Heat Sterilization

[B490501309A0]

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 Gluteal Implant]

• B490501604B0: Gluteal Sty 6 Sz 4 Sterile
• B4905016047A0: Gluteal Sty 6 Sz 4 w/ BL/ST Sterile
• B490501603B0: Gluteal Sty 6 Sz 3 Sterile
• B4905016039A0: Gluteal Sty 6 Sz 3 w/ST Sterile
• B4905016037A0: Gluteal Sty 6 Sz 3 w/ BL/ST Sterile
• B490501602B0: Gluteal Sty 6 Sz 2 Sterile
• B4905016027A0: Gluteal Sty 6 Sz 2 w/ BL/ST Sterile
• B490501601B0: Gluteal Sty 6 Sz 1 Sterile
• B4905016017A0: Gluteal Sty 6 Sz 1 w/ BL/ST Sterile
• B490501310A0: Gluteal Sty 3 Sz 10 Sterile
• B4905013109A0: Gluteal Sty 3 Sz 10 w/ ST Sterile
• B4905013103A0: Gluteal Sty 3 Sz 10,Smooth Sterile
• B490501309A0: Gluteal Sty 3 Sz 9 Sterile
• B4905013099A0: Gluteal Sty 3 Sz 9 w S/T
• B490501308A0: Gluteal Sty 3 Sz 8 Sterile
• B4905013083A0: Gluteal Sty 3 Sz 8 Smooth Sterile
• B490501307B0: Gluteal Sty 3 Sz 7 Sterile
• B490501306B0: Gluteal Sty 3 Sz 6 Sterile
• B4905013069A0: Gluteal Sty 3 Sz 6 Sterile
• B490501305B0: Gluteal Sty 3 Sz 5 Sterile
• B490501304B0: Gluteal Sty 3 Sz 4 Sterile
• B4905013049A0: Gluteal Sty 3 Sz 4 with ST Sterile
• B490501303B0: Gluteal Sty 3 Sz 3 Sterile
• B4905013039A0: Gluteal Sty 3 Sz 3 with ST Sterile
• B4905013037A0: Gluteal Sty 3 Sz 3 w/ BL/ST Sterile
• B4905013033A0: Gluteal Sty 3 Sz 3 Smooth, Sterile
• B490501302B0: Gluteal Sty 3 Sz 2 Sterile
• B4905013029A0: Gluteal Sty 3 Sz 2 w/ST Sterile
• B490501301B0: Gluteal Sty 3 Sz 1 Sterile
• B490501300B0: Gluteal Sty 3 Sz 0 Sterile
• B490501206B0: Gluteal Sty 2 Sz 6 Sterile
• B4905012067A0: Gluteal Sty 2 Sz 6 w/ BL/ST Sterile
• B490501205B0: Gluteal Sty 2 Sz 5 Sterile
• B4905012059B0: Gluteal Sty 2 Sz 5 w/ST Sterile
• B490501204B0: Gluteal Sty 2 Sz 4 Sterile
• B4905012049A0: Gluteal Sty 2 Sz 4 w/ST Sterile
• B490501203B0: Gluteal Sty 2 Sz 3 Sterile
• B4905012039A0: Gluteal Sty 2 Sz 3 w/ST Sterile
• B490501202B0: Gluteal Sty 2 Sz 2 Sterile
• B490501201B0: Gluteal Sty 2 Sz 1 Sterile
• B490501106C0: Gluteal Sty 1 Sz 6 Sterile
• B4905011069A0: Gluteal Sty 1 Sz 6 w/ST Sterile
• B490501105B0: Gluteal Sty 1 Sz 5 Sterlie
• B490501104B0: Gluteal Sty 1 Sz 4 Sterile
• B490501103B0: Gluteal Sty 1,Sz 3.Sterile
• B4905011039A0: Gluteal Sty 1,Sz 3.w/ST, Sterile
• B490501102B0: Gluteal Sty 1 Sz 2 Sterile
• B490501101B0: Gluteal Sty 1 Sz 1 Sterile