NMCT

GUDID 00840682140836

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00840682140836
• NIH Device Record Key: 029858ee-9de1-4d88-aa56-5ff2bb707f99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NMCT
• Version Model Number: 870 DR
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682140836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093514

FDA Product Code

• JAK: System, x-ray, tomography, computed

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: 2018-05-17

On-Brand Devices [NMCT]

• 00840682140843: 870CZT
• 00840682140836: 870 DR
• 00840682140775: 850
• 00840682140751: 860
• 00195278788269: 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE