Hana Orthopedic Surgery Table (int'l)

Basic Information

• Brand Name: Hana Orthopedic Surgery Table (int'l)
• Primary DI: 00842430107474
• Version / Model: 6875I
• Catalog Number: 6875I
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-08
• Public Version: 2
• Public Version Date: 2021-09-24
• Public Version Status: Update
• Public Device Record Key: a8634846-afda-45a9-9b47-bd135d16e1da

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
JEA	Table, Surgical With Orthopedic Accessories, Ac-Powered	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45400	Orthopaedic operating table, electromechanical	A mobile, electrically-powered motorized table designed to support a patient and to provide traction for the limb(s)/spine of the patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted, and it is often intended to be used with additional patient positioners. It may have x-ray transparent features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430107474	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 100 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -4 – 122 Degrees Fahrenheit