EQUATE

Basic Information

• Brand Name: EQUATE
• Primary DI: 00194346098057
• Version / Model: FGP507EQ WMRT
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 1
• Public Version Date: 2023-08-14
• Public Version Status: New
• Public Device Record Key: e9820f84-ae88-4e2a-ad0b-7f60f195ad04

Device Description

EQ ADAPTIVE CUTLERY

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
ILC	Utensil, Eating	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31197	Assistive cutlery	A device designed as an eating utensil (e.g., a specialized knife, spoon, or fork) used by a person with a disability to cut food and/or to transfer food into their mouth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30194346098058	GS1		4	In Commercial Distribution
Primary	00194346098057	GS1

Customer Contacts

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