NM 5376204-33

GUDID 00195278788252

830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00195278788252
• NIH Device Record Key: c0172f56-69b2-4626-b288-8eb2946c427d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NM
• Version Model Number: 830
• Catalog Number: 5376204-33
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278788252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111445

FDA Product Code

• KPS: System, tomography, computed, emission

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: 2023-11-23
• Device Publish Date: 2023-11-15

On-Brand Devices [NM]

• 00840682140829: 830
• 00195278788252: 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE