Best Precision Stepper

Basic Information

• Brand Name: Best Precision Stepper
• Primary DI: 00852656007083
• Version / Model: C-0000939
• Company Name: Best Nomos
• Labeler DUNS: 146920025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: aa5ddc54-6b72-411f-a7e2-fadb795179db

Device Description

The Precision Stepper is designed to hold and manipulate an ultrasound rectal probe during prostate therapy. The Precision Stepper is used for assisting the physician in placement of the Ultrasound Transducer and Brachytherapy needles for prostate brachytherapy procedures. The Precision Stepper is intended to be mounted onto a stabilizing device such as the Best Precision Stabilizer

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: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWJ	System, Applicator, Radionuclide, Manual	Radiology	892.5650	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37050	Medical table clamp	A device that is designed to be used together with operating tables and certain kinds of examination/treatment tables. It can have different fixation/locking mechanisms, but is often designed to fit onto the side rails of such tables. It is used to hold different components and accessories onto the table providing added functionality. Such devices can be footrests, transducer holders, anaesthesia screen holders. The clamp allows for easy and safe adjustments of the position of these accessory devices and provides a secure locking mechanism. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852656007083	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973786	000