Aseptico

GUDID 10817417021620

Custom Cart Delivery

ASEPTICO, INC.

Dental delivery system

• Primary Device ID: 10817417021620
• NIH Device Record Key: 37ccfb43-5cd1-4fbc-b1b9-8ac971ccb4bb
• Commercial Distribution Discontinuation: 2032-11-02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aseptico
• Version Model Number: ADU-25
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817417021620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905401

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

[10817417021620]

Moist Heat or Steam Sterilization

[10817417021620]

Moist Heat or Steam Sterilization

[10817417021620]

Moist Heat or Steam Sterilization

[10817417021620]

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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• 10817417020906: Electronic Endodontic System
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