BlueSkiBio

GUDID 10817417020753

The AEU-1000BSB-70V dental Implant Motor System with variable-speed footswitch Blue Sky Bio is a drive system for instruments and tools used in dentistry for implant procedures.

ASEPTICO, INC.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 10817417020753
• NIH Device Record Key: 145b821b-49ab-42cd-bbae-5ad177a9760b
• Commercial Distribution Discontinuation: 2032-07-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlueSkiBio
• Version Model Number: AEU-1000BSB-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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417020753 [Primary]

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

[10817417020753]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-22
• Device Publish Date: 2022-07-14

Devices Manufactured by ASEPTICO, INC.

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• 10817417020203 - Aseptico: 2023-05-11 Portable Dental Lamp
• 10817417020210 - Aseptico: 2023-05-11 Portable Dental Lamp
• 10817417020111 - Aseptico: 2023-03-27 Dental Implant Motor System
• 10817417020128 - Aseptico: 2023-03-27 Dental Implant Motor System
• 10817417020142 - Aseptico: 2023-03-27 Dental Implant Motor System
• 10817417020159 - Aseptico: 2023-03-27 Dental Implant Motor System