StarGuide 5842898-10

GUDID 00195278755544

StarGuide NM GANTRY MDR FINAL

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00195278755544
• NIH Device Record Key: 4f8190ba-24a8-4b3a-b387-b85191c8fbf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarGuide
• Version Model Number: H3911BJ
• Catalog Number: 5842898-10
• 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	00195278755544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210173

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: 2024-04-26
• Device Publish Date: 2024-04-18

On-Brand Devices [StarGuide]

• 00195278118295: STARGATE NM GANTRY FINAL
• 00195278755544: StarGuide NM GANTRY MDR FINAL