Clear Eye Shield - Non-sterile

Basic Information

• Brand Name: Clear Eye Shield - Non-sterile
• Primary DI: 00813465012156
• Version / Model: 9401
• Catalog Number: 9401
• Company Name: HURRICANE MEDICAL INC
• Labeler DUNS: 093377724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• 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: 04038497-960d-4c60-8e79-39c99715608d

Device Description

Protects the eye during or after surgery, or after trauma. Universal for left or right eye.

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35063	Eye mask	A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10813465012153	GS1
Primary	00813465012156	GS1