830 to 860 Upgrade

GUDID 00840682145497

G E MEDICAL SYSTEMS ISRAEL LTD.

Stationary gamma camera system

• Primary Device ID: 00840682145497
• NIH Device Record Key: 45d94d86-eef8-4bc8-97a6-46dfd6023316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 830 to 860 Upgrade
• Version Model Number: H3908AP
• 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	00840682145497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173816

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: 2019-05-14
• Device Publish Date: 2019-05-06

On-Brand Devices [830 to 860 Upgrade]

• 00840682145497: H3908AP
• 00840682145473: H3908AM