RIC10-D 5845346

GUDID 00195278283375

RIC10-D

GE Healthcare Austria GmbH & Co OG

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00195278283375
NIH Device Record Keyaf4dc973-05d1-4738-ad59-f10eb4820c39
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIC10-D
Version Model NumberRIC10-D
Catalog Number5845346
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 Datefalse
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 HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Handling Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 0 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278283375 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-19
Device Publish Date2023-10-11

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-D2023-10-19RIC10-D
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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