AART Nasal Implant 402-505A

GUDID B490402505A0

Nasal Sty 5 Sterile

Aart

Nasal implant, synthetic polymer, non-bioabsorbable Nasal implant, synthetic polymer, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable Nasal cartilage support implant, non-bioabsorbable

• Primary Device ID: B490402505A0
• NIH Device Record Key: eeeede42-cd3f-4584-b6c9-d5f36361f5d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Nasal Implant
• Version Model Number: A
• Catalog Number: 402-505A
• 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
• 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
• 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
• 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	B490402505A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021418

FDA Product Code

• FZE: PROSTHESIS, NOSE, INTERNAL

Sterilization

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

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

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[B490402505A0]

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[B490402505A0]

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[B490402505A0]

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[B490402505A0]

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[B490402505A0]

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[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

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[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

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[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

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[B490402505A0]

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[B490402505A0]

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[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

Dry Heat Sterilization

[B490402505A0]

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 Nasal Implant]

• B490402505B0: Nasal Sty 5 Sterile
• B490402505A0: Nasal Sty 5 Sterile
• B490402404B0: Nasal Sty 4 Sterile
• B490402404A0: Nasal Sty 4 Sterile
• B490402303B0: Nasal Sty 3 Sterile
• B490402303A0: Nasal Sty 3 Sterile
• B490402202B0: Nasal Sty 2 Sterile
• B490402101B0: Nasal Sty 1 Sterile