Eye Shield

Basic Information

• Brand Name: Eye Shield
• Primary DI: 00841439107775
• Version / Model: MTT45M
• Catalog Number: MTT45M
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-02
• Public Version: 8
• Public Version Date: 2023-06-26
• Public Version Status: Update
• Public Device Record Key: fd6e57c4-db1b-493b-b4d7-b4459180f2d3
• Distribution End Date: 2023-06-26

Device Description

Eye Shield - Medium

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWS	Shield, eye, radiological	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64271	Radiation/mechanical corneal shield, reusable	A protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841439107775	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K945515	000

Device Sizes

Type	Value	Unit	Text
Length	1.06	Inch
Width	1	Inch