Reusable Surgical Optical Fibe

GUDID 08033945933692

Reusable 10x Surgical Optical Fiber Ø 550 µm

QUANTA SYSTEM SPA

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 08033945933692
• NIH Device Record Key: 9c3f0b41-e17f-41fc-9312-65d73fd3f46a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Surgical Optical Fibe
• Version Model Number: OAF005503
• 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: false
• 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	08033945933692 [Primary]
GS1	08033945935382 [Package]; Package: carton [5 Units]; In Commercial Distribution
GS1	08033945935696 [Package]; Contains: 08033945935382; Package: carton [2 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

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

[08033945933692]

Moist Heat or Steam Sterilization;Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-07
• Device Publish Date: 2016-08-29

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