rC60xi/5-2 MHz Armored

GUDID 00841517100551

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100551
NIH Device Record Keya125c00d-1e92-4a64-a7cf-24a7a2c32db2
Commercial Distribution StatusIn Commercial Distribution
Brand NamerC60xi/5-2 MHz Armored
Version Model NumberP21636-10A
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
GS100841517100551 [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 [rC60xi/5-2 MHz Armored]

00841517104917P21636-20
00841517100551P21636-10A
00841517100544P21636-10
00841517106157P21636-20A
00841517107147Diagnostic Ultrasound Transducer
00841517109097Diagnostic ultrasound transducer
00841517110413P21636-21A

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