Corneal Light Shield 9205

GUDID 00813465012118

Protects the retina from intense operating microscope light during ophthalmic surgery.

HURRICANE MEDICAL INC

Ophthalmic sponge

• Primary Device ID: 00813465012118
• NIH Device Record Key: 0a422562-b3a0-4a82-abbd-dbbb60fa8cf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Corneal Light Shield
• Version Model Number: 9205
• Catalog Number: 9205
• Company DUNS: 093377724
• Company Name: HURRICANE MEDICAL INC
• Device Count: 20
• 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

Customer Support Contacts

• Phone: 9417510588
• Email: david@hurricanemedical.com

Device Dimensions

• Outer Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813465012118 [Primary]
GS1	10813465012115 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990671

FDA Product Code

• HOZ: Sponge, Ophthalmic

Sterilization

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

[00813465012118]

Radiation Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-14
• Device Publish Date: 2016-04-26

On-Brand Devices [Corneal Light Shield]

• 00813465012095: Protects the retina from intense operating microscope light during ophthalmic surgery.
• 00813465012088: Protects the retina from intense operating microscope light during ophthalmic surgery.
• 00813465012118: Protects the retina from intense operating microscope light during ophthalmic surgery.