Probe Navigator

Basic Information

• Brand Name: Probe Navigator
• Primary DI: 04057217005782
• Version / Model: C02 301
• Company Name: Z-Medical GmbH + Co. KG
• Labeler DUNS: 332068761
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-17
• Public Version: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: a51f7ca3-1881-40c1-b69b-0ef5e7b6ff57

Device Description

Guide curved 140mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
GZX	Instrument, Microsurgical	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61226	Invasive vascular ultrasound system probe	A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04057217005782	GS1

Customer Contacts

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