R82

Basic Information

• Brand Name: R82
• Primary DI: 05707292863652
• Version / Model: Rabbit Up SIZE-01
• Catalog Number: 8621224-21
• Company Name: R82 A/S
• Labeler DUNS: 308022169
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-12
• Public Version: 1
• Public Version Date: 2022-10-20
• Public Version Status: New
• Public Device Record Key: 18d22306-017b-4e29-a738-09892a25b15d

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
INW	TABLE, MECHANICAL	Physical Medicine	890.3750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61700	Manual stander	A manually-powered, mobile device designed to support and lift a disabled (paraplegic) patient to an upright standing position to provide the health benefits associated with standing (e.g., improved breathing, circulation, and flexibility); it is neither intended to facilitate gait nor assist standing transfer. It typically consists of a seat, sling and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), wheels, and a manual mechanical lifting mechanism whereby the patient is raised from a supine, prone, and/or seated position by themselves or with the assistance of a healthcare provider. It includes wheels for reorientation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05707292863652	GS1