CRANK HANDLE W/TORQUE LIMITER

Basic Information

• Brand Name: CRANK HANDLE W/TORQUE LIMITER
• Primary DI: 00842430110191
• Version / Model: 5319-6
• Catalog Number: 5319-6
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 1
• Public Version Date: 2019-07-01
• Public Version Status: New
• Public Device Record Key: f8d1dff9-92c0-4c5d-9fa5-b568e42ba35d

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

GMDN Terms

Code	Name	Definition	Implantable	Status
62890	Operating table handcrank	A manually-operated mechanical device intended to be used to enable operation and adjustment of an operating table and its associated devices, including table tops, patient positioners, and positioning pads. It may be employed in normal operation or as backup when the electrical system and/or motors of an operating table have failed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842430110191	GS1

Customer Contacts

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