StarGuide

GUDID 00195278118295

STARGATE NM GANTRY FINAL

G E MEDICAL SYSTEMS ISRAEL LTD.

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

On-Brand Devices [StarGuide]

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