EZ WIDER, FOOT WIDTH EXTENSION - RH

Basic Information

• Brand Name: EZ WIDER, FOOT WIDTH EXTENSION - RH
• Primary DI: 00850520008099
• Version / Model: ASM200114
• Company Name: KREG MEDICAL INC.
• Labeler DUNS: 079220324
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 1
• Public Version Date: 2020-06-22
• Public Version Status: New
• Public Device Record Key: ad76ca7d-199d-424e-83f7-b169e56dcef0

Device Description

Food Width Extension - RH

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: Yes
• 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
KIC	Cushion, Flotation	Physical Medicine	890.3175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41058	Multifunction body cushion	A soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850520008099	GS1

Customer Contacts

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