Reusable Surgical Optical Fiber

GUDID 08059173390298

Reusable 10x Gastro Surgical Optical Fiber ø 272 µm

QUANTA SYSTEM SPA

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 08059173390298
• NIH Device Record Key: 24cf06f8-ac0e-4130-94b6-270353aa8d6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Surgical Optical Fiber
• Version Model Number: OAF102713
• Company DUNS: 436045833
• Company Name: QUANTA SYSTEM SPA
• 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: true
• Expiration Date: true
• 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	08059173390274 [Primary]
GS1	08059173390281 [Package]; Package: carton box [2 Units]; In Commercial Distribution
GS1	08059173390298 [Package]; Contains: 08059173390274; Package: carton box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160513

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08059173390298]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

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• 08059173392049: Reusable 5x Precision Surgical Optical Fiber ø 365µm
• 08059173392018: Reusable 5x Surgical Optical Fiber ø 272 µm
• 08059173391981: Reusable 5x Surgical Optical Fiber Ø 272 µm
• 08059173391950: Reusable 5x Surgical Optical Fiber ø 272 µm Precision
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• 08033945938765: Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Amer
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• 08033945938116: Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies Amer
• 08033945937966: Reusable 10x Surgical Optical Fiber ø 1000 µm. Distributed by Olympus Surgical Technologies Am
• 08033945937843: Reusable 10x Surgical Optical Fiber ø 550 µm. Distributed by Olympus Surgical Technologies Ame
• 08033945937720: Reusable 10x Surgical Optical Fiber ø 200µm. Distributed by Olympus Surgical Technologies Amer
• 08033945937430: Reusable 10X Surgical Optical Fiber ø 800 µm. Distributed by Cogentix.
• 08033945937423: Reusable 10X Surgical Optical Fiber ø 550 µm. Distributed by Cogentix.
• 08033945937416: Reusable 10X Surgical Optical Fiber ø 365 µm. Distributed by Cogentix.
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• 08033945937164: Reusable 10x Surgical Optical Fiber Ø 365 µm
• 08033945937133: Reusable 10x Surgical Optical Fiber ø 272µm
• 08033945937102: Reusable 10x Surgical Optical Fiber ø 200 µm
• 08033945936693: Reusable 10x Precision Surgical Optical Fiber ø 365 µm
• 08033945936686: Reusable 10x Precision Surgical Optical Fiber ø 272µm
• 08033945936679: Reusable 10x Precision Surgical Optical Fiber ø 365 µm
• 08033945936662: Reusable 10x Precision Surgical Optical Fiber ø 272µm
• 08033945936655: Reusable 10x Precision Surgical Optical Fiber ø 365 µm
• 08033945936648: Reusable 10x Precision Surgical Optical Fiber ø 272µm
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• 8033945936327: Reusable 10x Surgical Optical Fiber Ø 800 µm Manufactured for Edap Technomed Inc.
• 8033945936310: Reusable 10x Surgical Optical Fiber Ø 550 µm Manufactured for Edap Technomed Inc.
• 8033945936303: Reusable 10x Surgical Optical Fiber Ø 365 µm Manufactured for Edap Technomed Inc.
• 8033945936297: Reusable 10x Surgical Optical Fiber ø 272 µm Manufactured for Edap Technomed Inc.
• 8033945936280: Reusable 10x Surgical Optical Fiber ø 200µm Manufactured for Edap Technomed Inc.
• 08033945934880: Reusable 10x Surgical Optical Fiber Ø 400 µm
• 08033945934491: Reusable 10x Surgical Optical Fiber Ø 272 µm
• 08033945934460: Reusable 10x Surgical Optical Fiber ø 200 µm
• 08033945934439: Reusable 10x Surgical Optical Fiber Ø 1000 µm
• 08033945934415: Reusable 10x Surgical Optical Fiber Ø 800 µm
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• 08033945934385: Reusable 10x Surgical Optical Fiber Ø 400 µm
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