Synergetics 56.02P

GUDID 10841305100692

Endo Illuminator

SYNERGETICS USA, INC.

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 10841305100692
• NIH Device Record Key: 6747c7c0-5260-4275-bb66-2f6b0fc3e7a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergetics
• Version Model Number: 56.02P
• Catalog Number: 56.02P
• Company DUNS: 021056726
• Company Name: SYNERGETICS USA, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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

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	10841305100692 [Primary]
GS1	20841305107179 [Package]; Package: Box [12 Units]; In Commercial Distribution

FDA Product Code

• MPA: Endoilluminator

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: 2020-06-23
• Device Publish Date: 2020-06-15

On-Brand Devices [Synergetics]

• 20841305111855: 20ga Stellaris PC Mid-Field Endoilluminator
• 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
• 20841305110872: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 9", 1.5mm Ti
• 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,
• 20841305110773: "The Lumenator™" Spetzler™-Malis® Disposable Lighted Bipolar Forceps, Bayonet, 8", 0.5mm Ti
• 20841305110612: 27ga VersaVIT 2.0™ Vitrectomy Probe
• 20841305110599: 25ga VersaVIT™ Vitrectomy Probe, 3ft
• 20841305110575: 23ga VersaVIT™ Vitrectomy Probe, 3ft
• 20841305110490: 25ga Stellaris PC Focal Endoilluminator
• 20841305110476: 23ga Stellaris PC Focal Endoilluminator
• 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
• 20841305110377: 25ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack
• 20841305110353: 23ga VersaVIT 2.0™ Core Essentials Biopsy Procedure Pack
• 20841305110339: 20ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Wide Field Illuminator
• 20841305110315: 27ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator
• 20841305110292: 20ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator
• 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
• 20841305110094: 23ga Stellaris PC Midfield Endoilluminator
• 20841305109982: 25ga Stellaris PC Vitrectomy Probe
• 20841305109968: 23ga Stellaris PC Vitrectomy Probe
• 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
• 20841305109555: 20ga VersaVIT™ Vitrectomy Probe, 6ft
• 20841305109494: 25ga Illuminated Directional II Laser Probe
• 20841305109487: 23ga Illuminated Directional II Laser Probe
• 20841305108848: Stiff 25ga Tano Diamond Dusted Membrane Scraper (DDMS™)
• 20841305108831: 23ga Tano Diamond Dusted Membrane Scraper (DDMS™)
• 20841305108527: 25ga VersaVIT 2.0™ Vitrectomy Probe
• 20841305108510: 23ga VersaVIT 2.0™ Vitrectomy Probe
• 20841305108503: 25ga VersaVIT 2.0™ Procedure Pack with PHOTON™ Wide Field Illuminator
• 20841305108497: 25ga VersaVIT 2.0™ Procedure Pack with Mid-Field Illuminator
• 20841305108480: 25ga VersaVIT 2.0™ Core Essentials Procedure Pack