INNOVA

GUDID 00840682108638

GE MEDICAL SYSTEMS

Stationary angiographic x-ray system, digital

• Primary Device ID: 00840682108638
• NIH Device Record Key: a60c5ba3-917e-4875-845d-d57013dd1696
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVA
• Version Model Number: IGS 630 002
• 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	00840682108638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122457

FDA Product Code

• JAA: System, x-ray, fluoroscopic, image-intensified

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-01

On-Brand Devices [INNOVA]

• 00840682121637: UPG X100 001
• 00840682147378: IGS 3 001
• 00840682124621: IGS 5 001
• 00840682124614: IGS 6 001
• 00840682110709: IGS 540 002
• 00840682110662: IGS 530 002
• 00840682110129: IGS 520 002
• 00840682108638: IGS 630 002
• 00840682108621: IGS 620 002