GUDID 00840682118057

GE Healthcare Austria GmbH & Co OG

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682118057
NIH Device Record Key45c7e454-2823-4175-95c3-fc7da424fcb2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4D3C-L
Company DUNS300599979
Company NameGE Healthcare Austria GmbH & Co OG
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(800)437-1171
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682118057 [Primary]

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-24
Device Publish Date2016-07-15

Devices Manufactured by GE Healthcare Austria GmbH & Co OG

00195278677587 - Voluson2023-11-23 Voluson Exp to BT24 UPG
00195278699848 - Voluson2023-11-23 Voluson Expert 22 BT24
00195278699800 - Voluson2023-11-15 Voluson Expert 18 BT24
00195278699824 - Voluson2023-11-15 Voluson Expert 20 BT24
00195278283375 - RIC10-D2023-10-19 RIC10-D
00195278347473 - Voluson2022-08-24 Voluson Expert 18
00195278347480 - Voluson2022-08-24 Voluson Expert 20
00195278347497 - Voluson2022-06-22 Voluson Expert 22

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