FOREARM REDUCTION UNIT

Basic Information

• Brand Name: FOREARM REDUCTION UNIT
• Primary DI: 00842430112928
• Version / Model: 3346
• Catalog Number: 3346
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 2
• Public Version Date: 2023-03-06
• Public Version Status: Update
• Public Device Record Key: b74536d3-bb84-462f-9b60-2ad943e70bbb
• Distribution End Date: 2023-02-28

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
HST	Apparatus, Traction, Non-Powered	Orthopedic	888.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35714	Orthopaedic casting stand	A structure/frame designed to hold and support a patient's torso or limb (arm or leg) in an appropriate position during an orthopaedic casting procedure. It typically consists of an adjustable base/pedestal and frame with a set of detachable components including limb-positioning attachments to maintain optimum joint alignment, supports for resting limbs, and blades for forming the cast. Typically the body part is placed on a blade and the cast material is wrapped around it; after completing the cast, the blade is removed from the cast to provide space for improved blood circulation and patient comfort. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430112928	GS1

Customer Contacts

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