Aseptico

GUDID 10817417020203

Portable Dental Lamp

ASEPTICO, INC.

Mobile examination/treatment room light

• Primary Device ID: 10817417020203
• NIH Device Record Key: 00d4b713-1a50-49d8-bc42-0934d71235fb
• Commercial Distribution Discontinuation: 2033-05-03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aseptico
• Version Model Number: ALU-40MOM
• Company DUNS: 016853348
• Company Name: ASEPTICO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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
• 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
• 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 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 45 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417020203 [Primary]

FDA Product Code

• EAZ: Light, Operating, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-11
• Device Publish Date: 2023-05-03

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• 10817417021033: Implant / Endodontic Dental Systems
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• 10817417020791: Dental Implant Motor System
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• 10817417021620: Custom Cart Delivery
• 10817417021491: Portable Hydraulic Dental Chair
• 10817417021484: Portable Hydraulic Dental Chair
• 10817417021477: Portable Hydraulic Dental Chair
• 10817417021460: Portable Dental Chair
• 10817417021453: Portable Pediatric Dental Chair
• 10817417021446: Portable Dental Chair
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• 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
• 10817417020852: Electronic Endodontic System
• 10817417020821: Electronic Endodontic System
• 10817417020159: Dental Implant Motor System
• 10817417020142: Dental Implant Motor System
• 10817417020128: Dental Implant Motor System
• 10817417020111: Dental Implant Motor System
• 10817417020210: Portable Dental Lamp
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