TRACTION LOAD SCALE W/CLAMP

Basic Information

• Brand Name: TRACTION LOAD SCALE W/CLAMP
• Primary DI: 00842430114113
• Version / Model: 3338
• Catalog Number: 3338
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-04
• Public Version: 1
• Public Version Date: 2021-01-12
• Public Version Status: New
• Public Device Record Key: b35a0984-7669-4660-aa15-759ea1797d42

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
62759	Surgical traction tensiometer, mechanical	A non-powered, graduated instrument intended to be used to measure the pulling force (traction) applied to a body part (e.g., hand, leg), typically during an orthopaedic surgical procedure. It is attached between a surgical traction tensioner and a patient-contact traction device (e.g., foot boot, hand wrap/trap) whereby the traction being pulled is displayed by a mechanical indicator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430114113	GS1

Customer Contacts

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