Opti-Gard

Basic Information

• Brand Name: Opti-Gard
• Primary DI: 10850017419329
• Version / Model: D28200CE-Brazil
• Catalog Number: D28200CE-Brazil
• Company Name: DUPACO, INC.
• Labeler DUNS: 093616555
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-10-30
• Public Version: 2
• Public Version Date: 2020-12-02
• Public Version Status: Update
• Public Device Record Key: 371ae58e-cada-4969-b085-d4050fff6178

Device Description

Opti-Gard SMALL CE NON-STERILE PACK, BRAZIL

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWS	Shield, eye, radiological	Radiology	892.6500	1
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58376	Eye splash shield, single-use	A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. 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	00850017419322	GS1
Primary	10850017419329	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 40 – 80 Degrees Fahrenheit