BOW

Basic Information

• Brand Name: BOW
• Primary DI: 00842430112911
• Version / Model: 3345
• Catalog Number: 3345
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 1
• Public Version Date: 2020-09-01
• Public Version Status: New
• Public Device Record Key: f136a6af-2681-4f98-829b-41dad2c0b923

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
46511	Surgical traction tensioner	A hand-operated tensioning device designed to be attached to a patient-contact device (e.g., hand wrap/trap, pelvic bone pin, foot boot, skull tongs) for the application of adjustable pulling force (traction) to a body part (e.g., leg, arm, hand, head, pelvis), typically during orthopaedic procedures (e.g., cervical spine surgery, pelvic reconstruction, fracture reduction). It may be a floor-standing pole or attached to an operating table or table extension, and typically consists of a multi-jointed structure with metal bars/posts, a manual screw/crank for traction adjustment, and mounting clamps/adaptors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430112911	GS1

Customer Contacts

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