rP19x/5-1 MHz Armored P21556

GUDID 00841517105112

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517105112
NIH Device Record Keyceef80b0-5cc6-4b50-9b1c-7281aa96757e
Commercial Distribution StatusIn Commercial Distribution
Brand NamerP19x/5-1 MHz Armored
Version Model NumberP21556-10A
Catalog NumberP21556
Company DUNS014438860
Company NameFUJIFILM SONOSITE, INC.
Device Count1
DM Exemptfalse
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

Phone+1(999)999-9999
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105112 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-11
Device Publish Date2019-10-03

On-Brand Devices [rP19x/5-1 MHz Armored]

00841517105112Diagnostic Ultrasound Transducer
00841517104931Diagnostic Ultrasound Transducer
00841517100605Diagnostic Ultrasound Transducer
00841517107161Diagnostic Ultrasound Transducer
00841517107611P21556-20A
00841517109080Diagnostic Ultrasound Transducer
00841517110420P21556-21A

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.