Discovery

GUDID 00840682125888

GE MEDICAL SYSTEMS

Stationary angiographic x-ray system, digital

• Primary Device ID: 00840682125888
• NIH Device Record Key: 5d86f9f5-2f42-459d-a2bc-21866d19f52a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Discovery
• Version Model Number: IGS 7 OR 001
• Company DUNS: 266062561
• Company Name: GE MEDICAL SYSTEMS
• 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	00840682125888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181403

FDA Product Code

• OXO: Image-Intensified Fluoroscopic X-Ray System, Mobile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-06
• Device Publish Date: 2018-02-10

On-Brand Devices [Discovery]

• 00840682125888: IGS 7 OR 001
• 00840682124638: IGS 7 001
• 00840682110693: IGS 740 002
• 00840682110648: IGS 730 002
• 00840682104739: IGS 730 001