SLA/13-6 MHz P05174

GUDID 00841517104108

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Surgical ultrasound imaging transducer
Primary Device ID00841517104108
NIH Device Record Key4bf43833-f239-45c3-b3b0-6e80bad632a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLA/13-6 MHz
Version Model NumberP05174-72
Catalog NumberP05174
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
GS100841517104108 [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 Date2018-09-13
Device Publish Date2018-08-13

Devices Manufactured by FUJIFILM SONOSITE, INC.

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00841517110604 - C5-12024-09-04 Diagnostic ultrasound system
00841517110611 - L19-52024-09-04 Diagnostic ultrasound system
00841517110628 - P5-12024-09-04 Diagnostic ultrasound system

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