Pencil probe

Basic Information

• Brand Name: Pencil probe
• Primary DI: 00894912002401
• Version / Model: P5M05S8A
• Catalog Number: P5M05S8A
• Company Name: KOVEN TECHNOLOGY, INC.
• Labeler DUNS: 069261402
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-29
• Public Version: 4
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 703e2c2e-5b90-4a71-b4d7-75a10fbf891f

Device Description

Reusable CW Doppler pencil probe, 5 MHz

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Hydrogen Peroxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOP	Transducer, Ultrasonic	Cardiovascular	870.2880	2

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	00894912002401	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K934638	000