Single Use Sterile Surgical Optical Fiber

GUDID 08059173390762

Single Use Lateral laser Fiber ø 600µm

QUANTA SYSTEM SPA

Urogenital surgical laser system beam guide, single-use

• Primary Device ID: 08059173390762
• NIH Device Record Key: 4e42d48a-3905-4e15-b2c8-bd80a0a19feb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Sterile Surgical Optical Fiber
• Version Model Number: OAF506001
• 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	08059173390755 [Primary]
GS1	08059173390762 [Package]; Contains: 08059173390755; Package: carton box [5 Units]; In Commercial Distribution
GS1	08059173390779 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-04-07
• Device Publish Date: 2020-05-27

On-Brand Devices [Single Use Sterile Surgical Optical Fiber ]

• 08059173390793: Single Use Lateral laser Fiber ø 600µm
• 08059173390762: Single Use Lateral laser Fiber ø 600µm
• 08059173390731: Single Use Lateral laser Fiber ø 600µm
• 08059173392698: Single Use Lateral laser Fiber ø 600µm