Senographe Pristina

GUDID 00840682118460

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital

• Primary Device ID: 00840682118460
• NIH Device Record Key: 09732d87-2cb8-4447-aea1-22adde39ea7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Senographe Pristina
• Version Model Number: EKB1
• 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

• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682118460 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-16

On-Brand Devices [Senographe Pristina]

• 00840682145879: EKB3
• 00840682142052: EKB2
• 00840682118460: EKB1
• 00195278223937: Senographe Pristina Core System
• 00195278276971: Senographe Pristina Core System
• 00195278022745: Senographe Pristina Core System
• 00195278665379: Senographe Pristina 3D UDI
• 00195278661999: Senographe Pristina 2D UDI