GUDID 00840682107846

GE Healthcare Austria GmbH & Co OG

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00840682107846
NIH Device Record Key89674fd4-4cef-47d0-9f18-5c49a9ea512d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRAB4-8-D
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

Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682107846 [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 Date2016-07-15

Devices Manufactured by GE Healthcare Austria GmbH & Co OG

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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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