LASIK Incise Film

Basic Information

• Brand Name: LASIK Incise Film
• Primary DI: 00813465011357
• Version / Model: 7309
• Catalog Number: 7309
• Company Name: HURRICANE MEDICAL INC
• Labeler DUNS: 093377724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-05-05
• Public Version: 1
• Public Version Date: 2020-05-13
• Public Version Status: New
• Public Device Record Key: 14b59a37-5097-44d0-824f-cfb6e5a58510

Device Description

Cover lashes, lids, and brows for LASIK, other refractive, or office procedures. Adhesive area 10 x 8.75 cm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Radiation Sterilization", "Ethylene Oxide"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34831	Hypoallergenic skin adhesive tape	A flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10813465011354	GS1
Primary	00813465011357	GS1

Device Sizes

Type	Value	Unit	Text
Length	12.5	Centimeter
Width	10	Centimeter