rC60xi/5-2 MHz Armored P21636

GUDID 00841517104917

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104917
NIH Device Record Keya6fdfc8b-99ac-49e1-8714-8d3b2b81033d
Commercial Distribution StatusIn Commercial Distribution
Brand NamerC60xi/5-2 MHz Armored
Version Model NumberP21636-20
Catalog NumberP21636
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 Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104917 [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 [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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