N/A 5244

GUDID 30818255011037

Disposable One-Step Trocar System, 25Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Trocar Cannula & 1 Infusion Line)

MICROVISION, INC.

Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use Ophthalmic cannulation set, single-use

• Primary Device ID: 30818255011037
• NIH Device Record Key: 5b13f04b-728c-450e-9378-6ab10dd7fb65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: 5244
• Company DUNS: 013486803
• Company Name: MICROVISION, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Device Dimensions

• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter
• Outer Diameter: 0.555 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight
• Special Storage Condition, Specify: Between 0 and 0 *caution
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818255011033 [Primary]
GS1	30818255011037 [Package]; Contains: 10818255011033; Package: carton [5 Units]; In Commercial Distribution

FDA Product Code

• NGY: Cannula, Trocar, Ophthalmic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-29
• Device Publish Date: 2018-04-04

On-Brand Devices [N/A]

• 10818255011088: Dual Bore Subretinal BSS Injection Needle, 23Ga. with 0.1mm/41Ga. tip
• 30818255011051: Disposable Viscous Fluid Injection Cannula, 23Ga. with 10mm thin-wall polyimide tip
• 30818255010887: Disposable Dual Bore PFC Cannula, 23Ga.
• 10818255010661: Charles Flute Cannula, 23Ga.
• 10818255010647: Retinal Cannula with Silicone Brush Tip, 23Ga.
• 10818255010630: Retinal Cannula with Silicone Top, 23Ga.
• 10818255010623: Retinal Cannula with Silicone Brush Tip, 25Ga.
• 10818255010593: Charles Flute Cannula, 25Ga.
• 30818255010566: Retinal Cannula with Silicone Tip, 25Ga.
• 30818255011037: Disposable One-Step Trocar System, 25Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Trocar Ca
• 30818255011020: Disposable Two-Step Trocar System, 23Ga. (3 Trocar Cannula Inserters with Pre-Loaded Self-Sealin
• 30818255010979: Disposable One-Step Trocar System, 23Ga. (3 Trocar Knives with Pre-Loaded Self-Sealing Trocar Ca
• 10818255010791: Fixation Plate and Marker for 23Ga. Vitrectomy
• 10818255010715: Reusable Two-Step Trocar System with Closure Plugs, 23Ga.
• 10818255010548: Disposable One-Step Trocar System, 25Ga. (4 insert handles with preloaded trocars & 1 infusion l
• 10818255010319: Scleral Plug Forceps