Grafco

Basic Information

• Brand Name: Grafco
• Primary DI: M3689677BL1
• Version / Model: 9677BL
• Catalog Number: 9677BL
• Company Name: GF HEALTH PRODUCTS, INC.
• Labeler DUNS: 132016168
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-06-09
• Public Version: 1
• Public Version Date: 2021-06-17
• Public Version Status: New
• Public Device Record Key: 70154d79-0c4e-423d-b0d5-4c037c77a9be

Device Description

SAFETY GLASSES, SIDESHIELDS-BL

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HQZ	Frame, Spectacle	Ophthalmic	886.5842	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64958	Eye splash shield, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	M3689677BL0	HIBCC
Primary	M3689677BL1	HIBCC

Customer Contacts

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