Discovery

GUDID 00840682139274

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00840682139274
• NIH Device Record Key: fca5e57c-d436-4038-b1a4-4b5b3b1b62d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discovery
• Version Model Number: NM 630
• 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	00840682139274 [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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-17

On-Brand Devices [Discovery]

• 00840682139403: NMCT 670 ES
• 00840682139380: NMCT 670 CZT
• 00840682139373: NMCT 670 PRO
• 00840682139359: 670 DR
• 00840682139274: NM 630
• 00840682124393: 670 DR
• 00840682123877: NMCT 670 ES
• 00840682123853: NMCT 670 CZT