HSL25x/13-6 MHz P20679

GUDID 00841517102388

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517102388
NIH Device Record Key961e5f33-2dbb-45b2-9403-1c6510ce73db
Commercial Distribution StatusIn Commercial Distribution
Brand NameHSL25x/13-6 MHz
Version Model NumberP20679-11
Catalog NumberP20679
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

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517102388 [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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-09-20

On-Brand Devices [HSL25x/13-6 MHz]

00841517104832Diagnostic Ultrasound Transducer
00841517102395Diagnostic Ultrasound Transducer
00841517102388Diagnostic Ultrasound Transducer
00841517102289Diagnostic Ultrasound Transducer
00841517100407Diagnostic Ultrasound Transducer
00841517105631P20679-20A
00841517107192P26001-03
00841517109059Diagnostic Ultrasound Transducer

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