INNOVA

GUDID 00840682120272

Hangwei GE Medical Systems Co., Ltd.

Stationary angiographic x-ray system, digital

• Primary Device ID: 00840682120272
• NIH Device Record Key: b24dfd8a-1ae4-4601-84b6-46d036099d78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INNOVA
• Version Model Number: IGS 540 ACT 001
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., 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	00840682120272 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091673

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-10

Devices Manufactured by Hangwei GE Medical Systems Co., Ltd.

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• 00195278798107 - Revolution: 2024-03-07 Revolution Ascend Sliding designated medical device
• 00195278788665 - Revolution Apex: 2024-01-03 Revolution Apex Select with Plus Edition - Designated System Medical Device
• 00195278526892 - Definium: 2023-09-26 Definium Pace Select system designated medical device
• 00195278713759 - NA: 2023-09-26 Galaxy 2.0 Wall Stand
• 00195278713766 - NA: 2023-09-26 Value Fixed Table
• 00195278686718 - Revolution: 2023-06-30 Revolution Maxima CT designated medical device