Surgical Sponge 9006

GUDID 00813465012057

The surgical sponge is used to absorb fluid from the surgical site during ophthalmic surgery.

HURRICANE MEDICAL INC

Ophthalmic sponge

• Primary Device ID: 00813465012057
• NIH Device Record Key: 6f58d770-53a0-4af2-8d05-778f8d419730
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Sponge
• Version Model Number: 9006
• Catalog Number: 9006
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813465012057 [Primary]
GS1	10813465012054 [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

[00813465012057]

Radiation Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-10
• Device Publish Date: 2016-04-26

Devices Manufactured by HURRICANE MEDICAL INC

• 10813465011132 - IOL Manipulator - Lester: 2020-05-18 Positioning of intraocular lens. Angled 10 mm from tip. Tip diameter 0.25 mm.
• 10813465011149 - IOL Manipulator - Sinskey: 2020-05-18 Positioning of intraocular lens. Angled 15 mm from tip. Tip dimensions: diameter 0.20 mm, length 0.50 mm.
• 10813465011163 - IOL Manipulator - Sinskey: 2020-05-18 Positioning of intraocular lens. Straight. Tip dimensions: diameter 0.20 mm, length 0.50 mm.
• 10813465011170 - Nucleus Chopper - P. Koch: 2020-05-18 Used to break-up nucleus within capsular bag during phacoemulsification. Angled 6 mm from tip. Tip dimensions: diameter 0.30 mm,
• 10813465011187 - Nucleus Chopper - Beckingsale: 2020-05-18 Used to break-up nucleus within capsular bag during phacoemulsification. Angled 11 mm from tip. Tip dimensions: diameter 0.30 mm
• 10813465011194 - Silicone Tubing: 2020-05-15 Tubing is used for making products similar to 6023, 6025, and 6027.
• 10813465011316 - Marker Pad - Gentian Violet: 2020-05-15 Used to coat corneal markers to imprint pattern on cornea.
• 10813465011323 - Marker Pad - Methylene Blue: 2020-05-15 Used to coat corneal markers to imprint pattern on cornea.