HYDROS TRUS Probe

GUDID 00850055427075

PROCEPT BIOROBOTICS CORPORATION

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00850055427075
NIH Device Record Key43c58bcb-22e6-4357-aa96-3c249a4c0a5d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYDROS TRUS Probe
Version Model NumberHU1000
Company DUNS016646472
Company NamePROCEPT BIOROBOTICS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com
Phone+1(650)232-7222
Emailcustomerservice@procept-biorobotics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850055427075 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


[00850055427075]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-16
Device Publish Date2024-09-06

Devices Manufactured by PROCEPT BIOROBOTICS CORPORATION

00850055427051 - HYDROS Handpiece2024-09-16
00850055427068 - HYDROS Robotic System2024-09-16
00850055427075 - HYDROS TRUS Probe2024-09-16
00850055427075 - HYDROS TRUS Probe2024-09-16
00850055427037 - AquaBeam Handpiece2023-12-25
00850055427044 - Lithotomy Drape2023-12-25
00850055427006 - AquaBeam Handpiece2023-09-04
00850055427013 - AquaBeam Scope2023-09-04
00850055427020 - AquaBeam Robotic System2023-09-04

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