L38v/10-5 MHz P19360

GUDID 00841517102005

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517102005
NIH Device Record Key028f4ca1-217d-4586-ac81-2db2e6e4bc84
Commercial Distribution StatusIn Commercial Distribution
Brand NameL38v/10-5 MHz
Version Model NumberP19360-18A
Catalog NumberP19360
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
Emailxyz@xyz.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517102005 [Primary]

FDA Product Code

ITXTransducer, ultrasonic, diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-23
Device Publish Date2017-03-07

On-Brand Devices [L38v/10-5 MHz]

00841517104047Diagnostic Ultrasound Transducer
00841517102005Diagnostic Ultrasound Transducer
00841517101879Diagnostic Ultrasound Transducer
00841517101435Diagnostic Ultrasound Transducer
00841517100889Diagnostic Ultrasound Transducer
00841517105662P19360-15A
00841517105174P19360-51
00841517106683Diagnostic Ultrasound Transducer
00841517107215P26082-02
00841517108571Diagnostic Ultrasound Transducer

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