Scoliometer

Basic Information

• Brand Name: Scoliometer
• Primary DI: 00842430108891
• Version / Model: 5280
• Catalog Number: 5280
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-02
• Public Version: 2
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: d0e53a8b-5a79-40a3-b47b-de924f68acac

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
HTH	Protractor	Orthopedic	888.4600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64817	Scoliometer	A non-powered, manually-operated measuring device, graduated in degrees, designed to measure the axial trunk rotation (ATR) of the spine for the assessment of scoliosis. It is placed transversely over the patient’s back, centred over the spinous process, after the patient has assumed a forward bending position for measuring degree of ATR at different vertebral levels (thoracic, lumbar). It is in the form of a plastic, rectangular ruler displaying a curved scale in degrees, typically with an indentation to centre over the spine, and containing a small ball which rolls along the scale to indicate degree of ATR. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430108891	GS1

Customer Contacts

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