HFL38xi/13-6 MHz P20311

GUDID 00841517104825

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104825
NIH Device Record Key60dd470a-156e-4f93-8173-e8259c70989a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHFL38xi/13-6 MHz
Version Model NumberP20311-20
Catalog NumberP20311
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 HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104825 [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 Date2019-08-01
Device Publish Date2019-07-24

On-Brand Devices [HFL38xi/13-6 MHz]

00841517104825Diagnostic Ultrasound Transducer
00841517104818Diagnostic Ultrasound Transducer
00841517100377Diagnostic Ultrasound Transducer
00841517100360Diagnostic Ultrasound Transducer
00841517105624P20311-20A
00841517106133Diagnostic Ultrasound Transducer
00841517107178Diagnostic Ultrasound Transducer
00841517109035Diagnostic Ultrasound Transducer
00841517109028Diagnostic Ultrasound Transducer

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