Eye, Artificial, Non-Custom

Basic Information

• Brand Name: Eye, Artificial, Non-Custom
• Primary DI: G519V2623
• Version / Model: V2623
• Company Name: Midwest Eye Laboratories Sioux Falls, LLC
• Labeler DUNS: 180954851
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-10
• Public Version: 1
• Public Version Date: 2024-03-18
• Public Version Status: New
• Public Device Record Key: bb7e7d4b-7723-40a9-a74c-25e8ce96fe39

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQH	Eye, Artificial, Non-Custom	Ophthalmic	886.3200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42522	Eyeball prosthesis, custom-made	An artificial substitute for the eyeball, resembling the anterior portion of the eye, made to individual specifications. It is usually constructed of glass or plastic and is intended to be inserted into a patient/user's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. This device is not intended to be implanted.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G519V2623	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 110 Degrees Fahrenheit