SenoClaire 5434135-5

GUDID 00840682100076

Digital Breast Tomosynthesis option for Senographe Essential

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital

• Primary Device ID: 00840682100076
• NIH Device Record Key: 3a15b29d-eb58-4972-9d5f-180f1c215147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SenoClaire
• Version Model Number: LLH2
• Catalog Number: 5434135-5
• 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 Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100076 [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: 2015-01-22

On-Brand Devices [SenoClaire]

• 00840682100076: Digital Breast Tomosynthesis option for Senographe Essential
• 00840682100045: Digital Breast Tomosynthesis option for Senographe Essential