Cover

Basic Information

• Brand Name: Cover
• Primary DI: 07350111832186
• Version / Model: 10-553
• Company Name: Reison Medical AB
• Labeler DUNS: 356766220
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-30
• Public Version: 1
• Public Version Date: 2022-05-09
• Public Version Status: New
• Public Device Record Key: 0af5426d-4270-4171-89f0-e965a59164bd

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: 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35993	Bedrail pad	A device which is formed as a flat or contoured fitted cushion made of soft, non-irritating materials designed to protect the patient from coming into contact with the bedrails and inadvertently hurting or injuring themselves. It will be mainly used for patients that have little self-control, infants and very young children. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350111832186	GS1