Aseptico

GUDID 10817417020906

Electronic Endodontic System

ASEPTICO, INC.

Dental surgical power tool motor, electric

• Primary Device ID: 10817417020906
• NIH Device Record Key: 3075c907-1f39-4d0e-ae11-1713d59a4377
• Commercial Distribution Discontinuation: 2032-11-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aseptico
• Version Model Number: AEU-27A
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417020906 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[10817417020906]

Moist Heat or Steam Sterilization

[10817417020906]

Moist Heat or Steam Sterilization

[10817417020906]

Moist Heat or Steam Sterilization

[10817417020906]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-15
• Device Publish Date: 2022-12-07

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• 10817417021620: Custom Cart Delivery
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• 10817417021484: Portable Hydraulic Dental Chair
• 10817417021477: Portable Hydraulic Dental Chair
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• 10817417021453: Portable Pediatric Dental Chair
• 10817417021446: Portable Dental Chair
• 10817417021422: Portable Dental Chair
• 10817417020999: Electric Operative Motor
• 10817417020982: Implant/ Endodontic Dental System
• 10817417020975: Implant / Endodontic Dental Systems
• 10817417020906: Electronic Endodontic System
• 10817417020890: Implant System
• 10817417020869: Electronic Endodontic System
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• 10817417020210: Portable Dental Lamp
• 10817417020203: Portable Dental Lamp
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