N/A 5188

GUDID 10818255010791

Fixation Plate and Marker for 23Ga. Vitrectomy

MICROVISION, INC.

Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable Ophthalmic cannulation set, reusable

• Primary Device ID: 10818255010791
• NIH Device Record Key: 7b9f8bcc-b57d-4861-a1d7-28373646b534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: N/A
• Catalog Number: 5188
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818255010791 [Primary]

FDA Product Code

• NGY: Cannula, Trocar, Ophthalmic

Sterilization

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

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

[10818255010791]

Moist Heat or Steam Sterilization

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