Triple Transducer Connect P16535

GUDID 00841517101558

Diagnostic Ultrasound System Accessory

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517101558
NIH Device Record Keybbc42ec8-8666-4964-b2f8-f55ae09e3ded
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriple Transducer Connect
Version Model NumberP16535-26R
Catalog NumberP16535
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
Emailxyz@xyz.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517101558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, imaging, pulsed doppler, ultrasonic

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 Date2016-10-21

On-Brand Devices [Triple Transducer Connect]

00841517102104Diagnostic Ultrasound System Accessory
00841517101626Diagnostic Ultrasound System Accessory
00841517101619Diagnostic Ultrasound System Accessory
00841517101602Diagnostic Ultrasound System Accessory
00841517101596Diagnostic Ultrasound System Accessory
00841517101558Diagnostic Ultrasound System Accessory
00841517101541Diagnostic Ultrasound System Accessory
00841517101473Diagnostic Ultrasound System Accessory
00841517101466Diagnostic Ultrasound System Accessory
00841517100193Diagnostic Ultrasound System Accessory
00841517100186Diagnostic Ultrasound System Accessory
00841517100179Diagnostic Ultrasound System Accessory
00841517100148Diagnostic Ultrasound System Accessory
00841517100131Diagnostic Ultrasound System Accessory
00841517103941Diagnostic Ultrasound System Accessory
00841517108090Diagnostic Ultrasound System Accessory
00841517108175Diagnostic Ultrasound System Accessory
00841517110352Diagnostic Ultrasound System Accessory
00841517110345Diagnostic Ultrasound System Accessory

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