L38xi/10-5 MHz P12742

GUDID 00841517104887

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104887
NIH Device Record Key985ad2e7-62c6-4aa0-b4d5-d2f082530777
Commercial Distribution StatusIn Commercial Distribution
Brand NameL38xi/10-5 MHz
Version Model NumberP12742-80
Catalog NumberP12742
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

Storage Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104887 [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 [L38xi/10-5 MHz]

00841517103316Diagnostic Ultrasound Transducer
00841517103156Diagnostic Ultrasound Transducer
00841517104993Diagnostic Ultrasound Transducer
00841517104887Diagnostic Ultrasound Transducer
00841517104870Diagnostic Ultrasound Transducer
00841517103477Diagnostic Ultrasound Transducer
00841517100476Diagnostic Ultrasound Transducer
00841517100469Diagnostic Ultrasound Transducer
00841517106898Diagnostic Ultrasound Transducer
00841517108991Diagnostic Ultrasound Transducer
00841517110505Diagnostic Ultrasound Transducer

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.