Weight Bearing DRP Holders

Basic Information

• Brand Name: Weight Bearing DRP Holders
• Primary DI: 00860001700176
• Version / Model: WDDR[X]
• Company Name: Reina Imaging
• Labeler DUNS: 102370137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-08
• Public Version: 1
• Public Version Date: 2023-06-16
• Public Version Status: New
• Public Device Record Key: 211b237b-3b75-4c61-ba7c-88716fb1b0c7

Device Description

Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor

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: No
• 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
FZM	Stool, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11772	Footstool	A platform, with or without legs, designed for a person to stand upon to compensate for differences in height or to place the feet/legs upon for rest/support when seated. It may be conductive to reduce the risk of static electricity when used in areas such as examination rooms or operating theatres, or non-conductive.	No	Active
64687	Flat panel x-ray detector/film cassette weight-bearing protector	A device intended to cover a flat panel x-ray detector or film cassette (neither included) on which a patient stands, to protect the cassette/detector from the patient’s body weight during a computed or digital radiography procedure of the feet. It is made of radiolucent materials with low x-ray attenuation/scattering. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860001700176	GS1

Customer Contacts

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