H-Universal Stand P12163

GUDID 00841517102135

Diagnostic Ultrasound System Accessory

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517102135
NIH Device Record Key70b410de-81f1-4475-aafc-e76429771153
Commercial Distribution StatusIn Commercial Distribution
Brand NameH-Universal Stand
Version Model NumberP12163-17
Catalog NumberP12163
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

Handling Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517102135 [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 Date2017-04-28

On-Brand Devices [H-Universal Stand]

00841517102173Diagnostic Ultrasound System Accessory
00841517102135Diagnostic Ultrasound System Accessory
00841517102067Diagnostic Ultrasound System Accessory
00841517101756Diagnostic Ultrasound System Accessory
00841517100070Diagnostic Ultrasound System Accessory
00841517105761Diagnostic Ultrasound System Accessory
00841517106430Diagnostic Ultrasound System Accessory
00841517108120Diagnostic Ultrasound System Accessory

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