P21x/5-1 MHz P07698

GUDID 00841517104900

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104900
NIH Device Record Key1f3d68d9-8d87-49b2-92b4-20a100016d07
Commercial Distribution StatusIn Commercial Distribution
Brand NameP21x/5-1 MHz
Version Model NumberP07698-80
Catalog NumberP07698
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

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104900 [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 [P21x/5-1 MHz]

00841517104900Diagnostic Ultrasound Transducer
00841517102937Diagnostic Ultrasound Transducer
00841517100537Diagnostic Ultrasound Transducer
00841517100520Diagnostic Ultrasound Transducer
00841517106294Diagnostic Ultrasound Transducer
00841517106881Diagnostic Ultrasound Transducer
00841517107529Diagnostic Ultrasound Transducer

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