UHF70 Transducer 51416

GUDID 00841517105464

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517105464
NIH Device Record Keyc47c5d4c-b420-4a4e-8bc5-83f63ff28567
Commercial Distribution StatusIn Commercial Distribution
Brand NameUHF70 Transducer
Version Model Number51416-51
Catalog Number51416
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 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105464 [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 [UHF70 Transducer]

00841517104696Diagnostic Ultrasound Transducer
00841517104535Diagnostic Ultrasound Transducer
00841517102357Diagnostic Ultrasound Transducer
00841517102340Diagnostic Ultrasound Transducer
00841517100742Diagnostic Ultrasound Transducer
00841517100735Diagnostic Ultrasound Transducer
0084151710547151416-51A
0084151710546451416-51

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