HYDROS TRUS Probe

Basic Information

• Brand Name: HYDROS TRUS Probe
• Primary DI: 00850055427075
• Version / Model: HU1000
• Company Name: PROCEPT BioRobotics Corporation
• Labeler DUNS: 016646472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-06
• Public Version: 3
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: 43c58bcb-22e6-4357-aa96-3c249a4c0a5d

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40771	Rectal/vaginal ultrasound imaging transducer	An invasive component of an ultrasound imaging assembly designed to be positioned within the vagina and/or rectum, either manually or under endoscopic guidance, for ultrasound imaging from within the vagina/rectum. Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to another device for display; it does not include an integrated display. It may be intended for wired or wireless data transfer and may be intended for use with a dedicated ultrasound system or with an off-the-shelf device (e.g., smartphone) with dedicated software installed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850055427075	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius