Optical Fiber Single Use

GUDID 08059173392551

Single use optical fiber Ø 150 µm

QUANTA SYSTEM SPA

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• Primary Device ID: 08059173392551
• NIH Device Record Key: 05870e67-f3c7-49a9-b78c-61d7f0d8708b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optical Fiber Single Use
• Version Model Number: FSI150
• 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: true
• 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	08059173392346 [Primary]
GS1	08059173392551 [Package]; Contains: 08059173392346; Package: Carton box [5 Units]; In Commercial Distribution
GS1	08059173392766 [Package]; Package: Carton box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200234

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Optical Fiber Single Use ]

• 08059173392551: Single use optical fiber Ø 150 µm
• 08059173393817: Single use optical fiber with 150 um diameter
• 08059173394449: Single use ball-tip optical fiber with 272 um diameter
• 08059173393893: Single use optical fiber with 272 um diameter
• 08059173393879: Single use Ball-tip optical fiber with 272 um diameter
• 08059173393848: Single use optical fiber with 200 um diameter