SenoClaire 5434135-4

GUDID 00840682100045

Digital Breast Tomosynthesis option for Senographe Essential

GE MEDICAL SYSTEMS

Stationary mammographic x-ray system, digital

• Primary Device ID: 00840682100045
• NIH Device Record Key: a687ca9a-d996-4f34-8c05-1c9225978e15
• Commercial Distribution Discontinuation: 2015-04-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SenoClaire
• Version Model Number: LLH1
• Catalog Number: 5434135-4
• 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 Humidity: Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100045 [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: 2014-09-24

On-Brand Devices [SenoClaire]

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