5228

GUDID 30818255010962

Chandelier Illuminator, 0.5mm Fiber with Ocutome Connector

MICROVISION, INC.

Ophthalmic fibreoptic light instrument, single-use

• Primary Device ID: 30818255010962
• NIH Device Record Key: a44c5a4c-32d1-41d7-bef5-545739a39273
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: NA
• Catalog Number: 5228
• Company DUNS: 013486803
• Company Name: MICROVISION, INC.
• 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: 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: 0.5 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	10818255010968 [Primary]
GS1	30818255010962 [Package]; Contains: 10818255010968; Package: Carton [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982462

FDA Product Code

• FFS: Image, Illumination, Fiberoptic, For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2018-01-17

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