NMCT

GUDID 00195278788269

870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00195278788269
• NIH Device Record Key: bf4dd765-da92-484f-8ef4-42b3ee878e41
• 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: 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	00195278788269 [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: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [NMCT]

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