00840682125833 Medical Device Identification

GUDID 00840682125833

GE HEALTHCARE JAPAN CORPORATION

Nonimplantable needle guide, reusable

Primary Device ID	00840682125833
NIH Device Record Key	c985e6e5-c019-4c37-885e-b7f2ff5036c4
Commercial Distribution Status	In Commercial Distribution
Version Model Number	ERB7_ERB Biopsy Attachment
Company DUNS	696021596
Company Name	GE HEALTHCARE JAPAN CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx
Phone	+1(800)437-1171
Email	xx@xx.xx

Operating and Storage Conditions

Handling Environment Temperature	Between -10 Degrees Celsius and 60 Degrees Celsius
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Handling Environment Temperature	Between 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Humidity	Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682125833 [Primary]

FDA Product Code

MJG	DEVICE, PERCUTANEOUS, BIOPSY

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2019-12-23
Device Publish Date	2017-11-15

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