GUDID 00840682145978

Hangwei GE Medical Systems Co., Ltd.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00840682145978
• NIH Device Record Key: b48d4a29-4076-4d25-a8e4-c5864fdff8a4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GCMWS-C5
• Company DUNS: 654659689
• Company Name: Hangwei GE Medical Systems Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00840682145978 [Primary]

FDA Product Code

• IXY: Holder, radiographic cassette, wall-mounted

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: 2019-09-18
• Device Publish Date: 2019-09-10

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• 00195278686718 - Revolution: 2023-06-30 Revolution Maxima CT designated medical device