C35x/8-3 Mhz P21981

GUDID 00841517104986

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104986
NIH Device Record Keye2ec6e86-c859-4cb9-b6b7-53c53d3d4e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameC35x/8-3 Mhz
Version Model NumberP21981-20
Catalog NumberP21981
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 HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104986 [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 Date2019-09-19
Device Publish Date2019-09-11

On-Brand Devices [C35x/8-3 Mhz]

00841517105013P21981-20A
00841517104986P21981-20
00841517100674Diagnostic Ultrasound Transducer
00841517101480P21981-10A
00841517109103DIAGNOSTIC ULTRAOSUND TRANSDUCER

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