Ultrafast Diode Laser 7300100

GUDID 00860179001044

Ultrafast Diode Laser

Dentlight Inc.

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system

• Primary Device ID: 00860179001044
• NIH Device Record Key: 99c39b2d-791b-4f78-9f1b-d16f2d3becdc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultrafast Diode Laser
• Version Model Number: 7300100
• Catalog Number: 7300100
• Company DUNS: 171208585
• Company Name: Dentlight 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	00860179001044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201387

FDA Product Code

• NVK: Laser, Dental, Soft Tissue

Sterilization

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

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

[00860179001044]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-01
• Device Publish Date: 2022-01-24

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