Senographe Pristina 3D

GUDID 00840682120142

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital

• Primary Device ID: 00840682120142
• NIH Device Record Key: cf2c7702-95ee-44f6-b256-24daa3cdbf3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senographe Pristina 3D
• Version Model Number: ATA1
• Company DUNS: 266062561
• Company Name: GE MEDICAL SYSTEMS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682120142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130020

FDA Product Code

• OTE: Digital breast tomosynthesis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-03-10

On-Brand Devices [Senographe Pristina 3D]

• 00840682120142: ATA1
• 00195278194039: Kit upgrade HW Single PC Infinity