Eye Shield

Basic Information

• Brand Name: Eye Shield
• Primary DI: 08052276029638
• Version / Model: AK-2000
• Catalog Number: AK-2000
• Company Name: AKTIVE SRL
• Labeler DUNS: 433533053
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2024-01-15
• Public Version: 1
• Public Version Date: 2024-01-23
• Public Version Status: New
• Public Device Record Key: 7962d250-85bc-413d-938d-999654229c50

Device Description

Eye Shield

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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: 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
65733	Postsurgical transparent eye shield, vented	A device designed to be worn over the eye to protect the eye while allowing the wearer to see, typically following ophthalmic surgery. It is designed as a transparent self-adhesive dome which includes vent holes to allow air to circulate around the eye. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08058340229232	GS1
Primary	08052276029638	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius