MP-2794-G16

GUDID 04573596210611

Puncture Guide Tube

FUJIFILM HEALTHCARE CORPORATION

Nonimplantable needle guide, reusable
Primary Device ID04573596210611
NIH Device Record Keyf80c0788-70d5-46aa-9ab3-c17b43fc7bdf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMP-2794-G16
Version Model NumberMP-2794-G16
Company DUNS718262719
Company NameFUJIFILM HEALTHCARE CORPORATION
Device Count1
DM Exempttrue
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

Device Dimensions

Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge
Needle Gauge16 Gauge

Operating and Storage Conditions

Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment TemperatureBetween -10 Degrees Celsius and 50 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS104562122957366 [Previous]
GS104573596210611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, Imaging, Pulsed Echo, Ultrasonic
OIJBiopsy Needle Guide Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


[04573596210611]

Ethylene Oxide;High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-26
Device Publish Date2021-07-18

Devices Manufactured by FUJIFILM HEALTHCARE CORPORATION

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04573596212318 - S3ESCLS2024-02-02 Probe
04573596212035 - L352024-01-30 Probe
04573596212455 - UST-2266-52024-01-30 Probe
04573596214176 - CL4416R12024-01-30 Probe
04573596214336 - C4212024-01-30 Probe
04573596214503 - CC41R22024-01-30 Probe

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