C60n/5-2 MHz

GUDID 00841517104245

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104245
NIH Device Record Key8a00e304-bba8-4d7f-a376-0d54b692b360
Commercial Distribution StatusIn Commercial Distribution
Brand NameC60n/5-2 MHz
Version Model NumberP11878-80A
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
GS100841517104245 [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 [C60n/5-2 MHz]

00841517104597Diagnostic Ultrasound Transducer
00841517104245Diagnostic Ultrasound Transducer
00841517104122Diagnostic Ultrasound Transducer
00841517101237Diagnostic Ultrasound Transducer
00841517100773Diagnostic Ultrasound Transducer

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