Diode Laser System Surgical Handpiece 6400105

GUDID 00647529000151

A reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical soft tissue applications.

BIOLASE, INC.

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• Primary Device ID: 00647529000151
• NIH Device Record Key: 17839cbd-a1b5-4d25-92fc-6d95723d7f5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diode Laser System Surgical Handpiece
• Version Model Number: 6400105
• Catalog Number: 6400105
• Company DUNS: 152165700
• Company Name: BIOLASE, 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: false
• 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: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com
• Phone: 1-800-321-6717
• Email: Diodeservice@biolase.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529000151 [Primary]
GS1	00647529000182 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121286

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

[00647529000151]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-22

On-Brand Devices [Diode Laser System Surgical Handpiece ]

• 00647529000199: A kit containing two (2) reusable surgical handpieces intended for use with Diode Laser Systems
• 00647529000151: A reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical