EdgePro 6200153

GUDID 00647529003572

A reusable fiberoptic tip accessory intended for use with EdgePro Laser System (Juno).

Biolase, Inc.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00647529003572
• NIH Device Record Key: 7abf1355-e560-4b09-b7c1-d7c18e57d2ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgePro
• Version Model Number: Tip Assembly - One-21 mm, WL JUNO
• Catalog Number: 6200153
• Company DUNS: 152165700
• Company Name: Biolase, Inc.
• Device Count: 1
• DM Exempt: true
• 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: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com
• Phone: 1-800-321-6717
• Email: Waterlaseservice@biolase.com

Device Dimensions

• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer
• Length: 21 Millimeter
• Outer Diameter: 200 Micrometer

Device Identifiers

Device Issuing Agency	Device ID
GS1	00647529003572 [Package]; Contains: 00647529004104; Package: Box [10 Units]; In Commercial Distribution
GS1	00647529004104 [Primary]
GS1	00647529004197 [Package]; Contains: 00647529004104; Package: Box [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213428

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

[00647529003572]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-27
• Device Publish Date: 2023-06-19

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