Synergetics 57.20

GUDID 10841305111087

Fiber Uniport Adapter (FUA), Alcon® Xenon

SYNERGETICS USA, INC.

Ophthalmic light source

• Primary Device ID: 10841305111087
• NIH Device Record Key: 5a511ac8-10a5-4c92-a777-0f77fa3b599c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergetics
• Version Model Number: 57.20
• Catalog Number: 57.20
• Company DUNS: 021056726
• Company Name: SYNERGETICS USA, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841305111087 [Primary]

FDA Product Code

• ONE: Powered light based non-laser surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-05-10
• Device Publish Date: 2020-09-18

On-Brand Devices [Synergetics]

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• 20841305111831: 20ga Stellaris PC Diffuse Wide-Field Endoilluminator
• 20841305111152: 20ga Stellaris PC Diffuse Wide-Field Endoilluminator
• 20841305111138: 20ga Stellaris PC Mid-Field Endoilluminator
• 20841305111053: 27ga Bipolar Cautery
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• 20841305110858: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 9", 1mm Tip,
• 20841305110834: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 9", .5mm Tip
• 20841305110810: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 1.5mm Ti
• 20841305110797: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 1mm Tip,
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• 20841305110490: 25ga Stellaris PC Focal Endoilluminator
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• 20841305110452: 20ga Irrigating Illuminated Capone Pick
• 20841305110438: 23ga Inverted Extendable Directional Laser Probe
• 20841305110414: 25ga Straight Fixed Extended Illuminated Laser Probe
• 20841305110391: 27ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack
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• 20841305110315: 27ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator
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• 20841305110278: 27ga VersaVIT 2.0™ Core Essentials Procedure Pack
• 20841305110254: 20ga VersaVIT 2.0™ Core Essentials Procedure Pack
• 20841305110216: 27ga Vivid Chandelier - Stellaris PC
• 20841305110193: 25ga Vivid Chandelier - Stellaris PC
• 20841305110179: 25ga Stellaris PC Diffuse Wide Field Endoilluminator
• 20841305110155: 23ga Stellaris PC Diffuse Wide Field Endoilluminator
• 20841305110131: 27ga Stellaris PC Midfield Endoilluminator
• 20841305110117: 25ga Stellaris PC Midfield Endoilluminator
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• 20841305109982: 25ga Stellaris PC Vitrectomy Probe
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• 20841305109715: 27ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Mid-Field Illuminator
• 20841305109692: 25ga VersaVIT 2.0™ Procedure Pack with Illuminated Directional Laser Probe
• 20841305109593: 23ga VersaVIT 2.0™ Procedure Pack with Illuminated Directional Laser Probe
• 20841305109562: 27ga VersaVIT™ Vitrectomy Probe, 6ft
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• 20841305109494: 25ga Illuminated Directional II Laser Probe
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