rP19x/5-1 MHz P21015

GUDID 00841517104948

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104948
NIH Device Record Keye0874de8-301c-4c78-9ce9-bcf00ec64291
Commercial Distribution StatusIn Commercial Distribution
Brand NamerP19x/5-1 MHz
Version Model NumberP21015-20
Catalog NumberP21015
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

Special Storage Condition, SpecifyBetween 0 and 0 *N/A

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104948 [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 [rP19x/5-1 MHz]

00841517104948Diagnostic Ultrasound Transducer
00841517100599Diagnostic Ultrasound Transducer
00841517100582Diagnostic Ultrasound Transducer
00841517106140Diagnostic Ultrasound Transducer
00841517107154Diagnostic Ultrasound Transducer
00841517109066Diagnostic Ultrasound Transducer
00841517110574Diagnostic Ultrasound Transducer

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