Pristina Serena

GUDID 00840682139229

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital

• Primary Device ID: 00840682139229
• NIH Device Record Key: 7e09b347-7218-4984-8377-4559ad8721ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pristina Serena
• Version Model Number: KAS1
• 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 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682139229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173576

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

On-Brand Devices [Pristina Serena]

• 00840682139229: KAS1
• 00195278347596: Biopsy Option