not applicable

GUDID 00840682143516

GE MEDICAL SYSTEMS

Mammographic x-ray system stereotactic unit

• Primary Device ID: 00840682143516
• NIH Device Record Key: 8a2463db-62e9-463f-9d8b-6e18cd81b915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: not applicable
• Version Model Number: PRISTINA 0.0
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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 Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682143516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162268

FDA Product Code

• MUE: Full field digital, system, x-ray, mammographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-24
• Device Publish Date: 2018-11-23

On-Brand Devices [not applicable]

• 00840682145862: PRISTINA 0.0A
• 00840682142373: PRISTINA 0.1
• 00840682143516: PRISTINA 0.0
• 00840682142038: M3-2 SP1 STD+
• 00840682125802: M3-2
• 00840682122603: 5727669
• 00195278009289: PRISTINA 0.0B
• 00840682146845: Software Pristina Infinity
• 00195278716026: UDI Software Pristina ME 9.1
• 00195278655141: Software Pristina 8.2 - ISO file
• 00195278711229: UDI Software Pristina
• 00195278795724: Software Pristina 8.3 - ISO file
• 00195278719812: Software Pristina ME 9.2 - ISO file
• 00195278866899: Software Pristina 8.4 - ISO file