GUDID 00840682107655

GE Healthcare Austria GmbH & Co OG

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00840682107655
NIH Device Record Key760894e9-d9fc-4c50-9bed-4f94c9ccee8f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4DE7C
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

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682107655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2018-07-06
Device Publish Date2016-07-15

Devices Manufactured by GE Healthcare Austria GmbH & Co OG

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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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