OCO Biomedical AEU-6000-OCO

GUDID 10817417021118

Implant / Endodontic Dental Systems

ASEPTICO, INC.

Dental surgical power tool motor, electric

• Primary Device ID: 10817417021118
• NIH Device Record Key: 4658091c-a1ae-4dc6-91dc-48d6c53b5c19
• Commercial Distribution Discontinuation: 2032-11-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OCO Biomedical
• Version Model Number: AEU-6000-OCO
• Catalog Number: AEU-6000-OCO
• 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: 14254873157
• Email: Regulatory@aseptico.com
• Phone: 14254873157
• Email: Regulatory@aseptico.com
• Phone: 14254873157
• Email: Regulatory@aseptico.com
• Phone: 14254873157
• Email: Regulatory@aseptico.com
• Phone: 14254873157
• 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	10817417021118 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[10817417021118]

Moist Heat or Steam Sterilization

[10817417021118]

Moist Heat or Steam Sterilization

[10817417021118]

Moist Heat or Steam Sterilization

[10817417021118]

Moist Heat or Steam Sterilization

[10817417021118]

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 [OCO Biomedical]

• 10817417020777: The AEU-1000-OCO Dental Implant Motor System is a drive system for instruments and tools used in
• 10817417021125: Implant / Endodontic Dental Systems
• 10817417021118: Implant / Endodontic Dental Systems