XPLUS 35 Series

GUDID 08800098700163

GEMSS Healthcare Co., Ltd.

Mobile general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: 08800098700163
• NIH Device Record Key: 97e1d33c-52c2-47c7-b2df-3a4379368473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPLUS 35 Series
• Version Model Number: XPLUS 35
• Company DUNS: 694184465
• Company Name: GEMSS Healthcare 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	08800098700163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233200

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2026-01-26
• Device Publish Date: 2026-01-16

On-Brand Devices [XPLUS 35 Series]

• 08800098700163: XPLUS 35
• 08800098700156: XPLUS 35FD