Reusable Surgical Optical Fiber EMP-FBX272HR-C

GUDID 08033945938277

Reusable 10x Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America. Gyrus ACMI, Inc.

QUANTA SYSTEM SPA

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 08033945938277
• NIH Device Record Key: 7b520890-ad0b-4456-bc0b-68206fd2c7ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reusable Surgical Optical Fiber
• Version Model Number: OFH002713
• Catalog Number: EMP-FBX272HR-C
• 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	08033945938253 [Primary]
GS1	08033945938260 [Package]; Contains: 08033945938253; Package: carton box [5 Units]; In Commercial Distribution
GS1	08033945938277 [Package]; Contains: 08033945938260; Package: carton box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180158

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

[08033945938277]

Hydrogen Peroxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-07
• Device Publish Date: 2018-03-07

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• 08033945936662: Reusable 10x Precision Surgical Optical Fiber ø 272µm
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• 08033945934880: Reusable 10x Surgical Optical Fiber Ø 400 µm
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