GUDID 00198953043295

Gemini Tilting WS

GE Hualun Medical Systems Co., Ltd

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00198953043295
• NIH Device Record Key: 99fec3fc-39a6-4fda-a5ee-22dd7d042668
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: GCEWS-C4
• Company DUNS: 554408665
• Company Name: GE Hualun 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	00198953043295 [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: 2025-04-30
• Device Publish Date: 2025-04-22

Devices Manufactured by GE Hualun Medical Systems Co., Ltd

• 00198953043288 - NA: 2025-04-30 Gemini_Non-tilting_WS
• 00198953043295 - NA: 2025-04-30Gemini Tilting WS
• 00198953043295 - NA: 2025-04-30 Gemini Tilting WS
• 00198953043301 - NA: 2025-04-30 Radiographic Table
• 00198953023259 - NA: 2025-03-10 G4 Non-Tilting Wallstand
• 00198953023266 - NA: 2025-03-10 G3A standard Wallstand