AIMGEN MAX PFX-3813SS-CA

GUDID 08800024954110

AIMGEN MAX Implant System Φ3.5/L12.5

Achimhai Medical Corporation

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• Primary Device ID: 08800024954110
• NIH Device Record Key: fd3332b0-76c1-45cb-af80-79f205837931
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIMGEN MAX
• Version Model Number: PFX-3813SS
• Catalog Number: PFX-3813SS-CA
• Company DUNS: 694197900
• Company Name: Achimhai Medical Corporation
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 1 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800024954110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172630

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-20
• Device Publish Date: 2022-01-12

On-Brand Devices [AIMGEN MAX]

• 08800024954639: AIMGEN MAX Implant System Φ3.5/L8.0
• 08800024953816: AIMGEN MAX Healing Abutment Φ7.5/H7.0
• 08800024953809: AIMGEN MAX Healing Abutment Φ7.5/H3.5
• 08800024953748: AIMGEN MAX Healing Abutment Φ7.5/H5.0
• 08800024953724: AIMGEN MAX Healing Abutment Φ3.0/H3.5
• 08800024953670: AIMGEN MAX Healing Abutment Φ3.5/H3.5
• 08800024953618: AIMGEN MAX Implant System Φ4.2/L8.0
• 08800024953557: AIMGEN MAX Implant System Φ4.2/L10.0
• 08800024953540: AIMGEN MAX Implant System Φ4.2/L7.0
• 08800024953496: AIMGEN MAX Implant System Φ5.1/L8.0
• 08800024953489: AIMGEN MAX Implant System Φ4.6/L15.0
• 08800024953472: AIMGEN MAX Implant System Φ4.6/L11.0
• 08800024953465: AIMGEN MAX Implant System Φ4.6/L8.0
• 08800024953458: AIMGEN MAX Implant System Φ4.2/L15.0
• 08800024953441: AIMGEN MAX Implant System Φ4.2/L11.0
• 08800024953434: AIMGEN MAX Implant System Φ5.1/L10.0
• 08800024953427: AIMGEN MAX Implant System Φ5.1/L7.0
• 08800024953410: AIMGEN MAX Implant System Φ4.6/L13.0
• 08800024953403: AIMGEN MAX Implant System Φ4.6/L10.0
• 08800024953397: AIMGEN MAX Implant System Φ4.6/L7.0
• 08800024953380: AIMGEN MAX Implant System Φ4.2/L13.0
• 08800024953373: AIMGEN MAX Internal Fixture Φ3.2/L14.5
• 08800024953366: AIMGEN MAX Internal Fixture Φ3.2/L11.0
• 08800024953335: AIMGEN MAX Implant System Φ5.5/L10.0
• 08800024953328: AIMGEN MAX Implant System Φ5.5/L7.0
• 08800024953311: AIMGEN MAX Cover screw M1.4
• 08800024953304: AIMGEN MAX Internal Fixture Φ3.2/L12.5
• 08800024953298: AIMGEN MAX Internal Fixture Φ3.2/L9.5
• 08800024953267: AIMGEN MAX Implant System Φ5.5/L8.0
• 08800024953250: AIMGEN MAX Healing Abutment Φ6.5/H5.0
• 08800024953243: AIMGEN MAX Healing Abutment Φ5.5/H7.0
• 08800024953236: AIMGEN MAX Healing Abutment Φ5.5/H3.5
• 08800024953229: AIMGEN MAX Healing Abutment Φ4.5/H5.0
• 08800024953212: AIMGEN MAX Healing Abutment Φ4.0/H7.0
• 08800024953205: AIMGEN MAX Healing Abutment Φ4.0/H3.5
• 08800024953199: AIMGEN MAX Healing Abutment Φ6.5/H7.0
• 08800024953182: AIMGEN MAX Healing Abutment Φ6.5/H3.5
• 08800024953175: AIMGEN MAX Healing Abutment Φ5.5/H5.0
• 08800024953168: AIMGEN MAX Healing Abutment Φ4.5/H7.0
• 08800024953151: AIMGEN MAX Healing Abutment Φ4.5/H3.5
• 08800024953144: AIMGEN MAX Healing Abutment Φ4.0/H5.0
• 08800024954127: AIMGEN MAX Implant System Φ3.5/L14.5
• 08800024954110: AIMGEN MAX Implant System Φ3.5/L12.5
• 08800024954103: AIMGEN MAX Implant System Φ3.5/L11.0
• 08800024954097: AIMGEN MAX Implant System Φ3.5/L9.5
• 08800024954073: AIMGEN MAX Implant System Φ3.5/L8.0
• 08800024954066: AIMGEN MAX Implant System Φ3.5/L7.0
• 08800024933610: AIMGEN MAX Implant System Φ3.2/L11.0
• 08800024933597: AIMGEN MAX Implant System Φ3.2/L10.0
• 08800024928722: AIMGEN MAX Implant System Φ3.2/L8.0