HSL25x/13-6 MHz P20679

GUDID 00841517105631

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517105631
NIH Device Record Keyfbbb225e-d8da-4e96-a2fa-c61941560695
Commercial Distribution StatusIn Commercial Distribution
Brand NameHSL25x/13-6 MHz
Version Model NumberP20679-20A
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

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105631 [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 Date2020-06-30
Device Publish Date2020-06-22

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
00841517110406Diagnostic Ultrasound Transducer

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