LASIK Drain 7301

GUDID 00813465011296

The LASIK drain channels fluid away from the surgical site during ophthalmic surgical procedure.

HURRICANE MEDICAL INC

Ophthalmic sponge

• Primary Device ID: 00813465011296
• NIH Device Record Key: 64dec4b0-84e1-4768-b2b8-fd30d5f9659e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LASIK Drain
• Version Model Number: 7301
• Catalog Number: 7301
• 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

• Lumen/Inner Diameter: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813465011296 [Primary]
GS1	10813465011293 [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

[00813465011296]

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 [LASIK Drain]

• 00813465011364: The LASIK drain channels fluid away from the surgical site during ophthalmic surgical procedure.
• 00813465011296: The LASIK drain channels fluid away from the surgical site during ophthalmic surgical procedure.