IVIS ImplantVision AEU-6000-IVS-70V

GUDID 10817417021088

Implant / Endodontic Dental Systems

ASEPTICO, INC.

Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric Dental surgical power tool motor, electric

• Primary Device ID: 10817417021088
• NIH Device Record Key: ead971fa-6305-4e6b-b5b6-8f003818ab09
• Commercial Distribution Discontinuation: 2032-11-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IVIS ImplantVision
• Version Model Number: AEU-6000-IVS-70V
• Catalog Number: AEU-6000-IVS-70V
• Company DUNS: 016853348
• Company Name: ASEPTICO, INC.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 425-487-3157
• Email: Regulatory@aseptico.com
• Phone: 425-487-3157
• Email: Regulatory@aseptico.com
• Phone: 425-487-3157
• Email: Regulatory@aseptico.com
• Phone: 425-487-3157
• Email: Regulatory@aseptico.com
• Phone: 425-487-3157
• Email: Regulatory@aseptico.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417021088 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[10817417021088]

Moist Heat or Steam Sterilization

[10817417021088]

Moist Heat or Steam Sterilization

[10817417021088]

Moist Heat or Steam Sterilization

[10817417021088]

Moist Heat or Steam Sterilization

[10817417021088]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-16
• Device Publish Date: 2022-11-08

On-Brand Devices [IVIS ImplantVision]

• 10817417020760: The AEU-1000-IVS-70V Dental Implant Motor System w/ Variable-Speed Footswitch ImplantVision is a
• 10817417021088: Implant / Endodontic Dental Systems