L38n/10-5 MHz

GUDID 00841517104115

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104115
NIH Device Record Keyac813ed4-2d7b-4518-9c66-ab5931b2cc54
Commercial Distribution StatusIn Commercial Distribution
Brand NameL38n/10-5 MHz
Version Model NumberP11877-85
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 TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104115 [Primary]

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 Date2018-12-31
Device Publish Date2018-11-29

On-Brand Devices [L38n/10-5 MHz]

00841517104238P11877-85A
00841517104221P11877-80A
00841517104115Diagnostic Ultrasound Transducer
00841517104078P11877-10A
00841517101343P11877-12A
00841517100841Diagnostic Ultrasound Transducer
00841517100834Diagnostic Ultrasound Transducer

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