StarGuide

GUDID 00195278118295

STARGATE NM GANTRY FINAL

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system Stationary gamma camera system

• Primary Device ID: 00195278118295
• NIH Device Record Key: 4545d2f0-e576-47d3-8fd6-f7136cdfcbbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarGuide
• Version Model Number: H3911AB
• Company DUNS: 532102365
• Company Name: G E MEDICAL SYSTEMS ISRAEL LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00195278118295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210173

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: 2021-05-18
• Device Publish Date: 2021-05-10

Devices Manufactured by G E MEDICAL SYSTEMS ISRAEL LTD.

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• 00195278788252 - NM: 2023-11-23 830 NM GANTRY FINAL WITH NEW ROTOR - MDR CE
• 00195278788269 - NMCT: 2023-11-22 870 DR NM GANTRY FINAL WITH NEW ROTOR - MDR CE
• 00195278488619 - MyoSPECT: 2023-09-22 MyoSPECT MDR GANTRY
• 00195278488626 - MyoSPECT ES: 2023-09-22 MyoSPECT ES MDR GANTRY
• 00195278722546 - MyoSEPCT ES to MyoSPECT Upgrade: 2023-09-22 MyoSPECT ES to MyoSPECT Upgrade kit
• 00195278592309 - Omni: 2022-09-20 OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY
• 00195278421579 - MyoSPECT ES: 2021-10-19 MyoSPECT ES GANTRY