Weight Bear

Basic Information

• Brand Name: Weight Bear
• Primary DI: 00860012977406
• Version / Model: OI-100
• Company Name: Orthios Innovations Llc
• Labeler DUNS: 119315375
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-16
• Public Version: 2
• Public Version Date: 2024-11-15
• Public Version Status: Update
• Public Device Record Key: 85f4cc5e-5654-49ee-bf4a-96c57b1c0e76
• Distribution End Date: 2030-01-01

Device Description

A device for simulating a weightbearing position on a patient's foot during surgery or in a clinical setting.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40900	Radiological arm/leg positioner	A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012977406	GS1

Customer Contacts

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