HFL38x/13-6 MHz

GUDID 00841517100322

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100322
NIH Device Record Key94f5fcde-9325-4fb9-b892-4d1e3e4d871d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHFL38x/13-6 MHz
Version Model NumberP07682-70
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

Phone1-877-657-8118
Emailffss-service@fujifilm.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100322 [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 Date2016-09-13

On-Brand Devices [HFL38x/13-6 MHz]

00841517105570Diagnostic Ultrasound Transducer
00841517104801Diagnostic Ultrasound Transducer
00841517102883Diagnostic Ultrasound Transducer
00841517100339Diagnostic Ultrasound Transducer
00841517100322Diagnostic Ultrasound Transducer
00841517106904Diagnostic Ultrasound Transducer
00841517107321Diagnostic Ultrasound Transducer

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