N/A TUI

GUDID 00852423006363

3.5-7.5 MHz Curvilinear Ultrasound Imaging_____ Doctor: Transperineal Ultrasound Imaging; P.T.: Pathway Ultrasound Imaging for Lumbo Pelvic Rehabilitation

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system Ultrasonic lithotripsy system
Primary Device ID00852423006363
NIH Device Record Key9ad15f15-15c3-4170-aadb-0b27936a501a
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberTUI
Catalog NumberTUI
Company DUNS625863568
Company NamePROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com
Phone1.800.442.2325
Emailinfo@theprogrp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852423006363 [Primary]

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-21
Device Publish Date2017-02-14

On-Brand Devices [N/A]

008524230063633.5-7.5 MHz Curvilinear Ultrasound Imaging_____ Doctor: Transperineal Ultrasound Imagin
00852423006301Uroflowmetry Load Cell
00852423006240Adapter for 7400 Disposable Lead Wire Electrodes
008524230062266’ Electrode Lead Wire Set
0085242300621924” Electrode Lead Wire Set
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