NA

Basic Information

• Brand Name: NA
• Primary DI: 10810050244845
• Version / Model: 9072
• Company Name: DOMICO MED-DEVICE, LLC
• Labeler DUNS: 081253414
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2021-10-07
• Public Version: 2
• Public Version Date: 2023-02-22
• Public Version Status: Update
• Public Device Record Key: d3e6ad8d-b293-4ac5-90f1-21a2ca82faa4
• Distribution End Date: 2023-02-17

Device Description

Protective Table Cover

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: Yes
• 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: 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
KXJ	Table, Radiologic	Radiology	892.1980	2
FMW	Cover, Mattress (Medical Purposes)	General Hospital	880.6190	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62720	Medical cushion cover	A device intended to cover a medical cushion (e.g., birthing cushion, lumbar cushion, wheelchair cushion) during use to protect the cushion from dirt/debris to maintain hygiene. It may be dedicated to a specific type of cushion or non-dedicated; it is not intended for surgical use and is not intended to cover a pillow primarily used in bed. 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	00810050244848	GS1
Primary	10810050244845	GS1