GXR-ES,ECS Diagnostic X-ray System

GUDID 08800011121877

The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device Identifier) is assigned based on the system model name, power specifications, and maximum x-ray tube voltage of the x-ray tube. *Power Specification (V) / maximum tube Voltage (kV) : 100-120 V~ / 125kV

DRGEM Corporation

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• Primary Device ID: 08800011121877
• NIH Device Record Key: f36e4609-b3ec-40a6-845e-973a60e3e5ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GXR-ES,ECS Diagnostic X-ray System
• Version Model Number: GXR-EC20S
• Company DUNS: 688477319
• Company Name: DRGEM Corporation
• 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: false
• 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	08800011121877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232178

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2023-11-06
• Device Publish Date: 2023-10-27

On-Brand Devices [GXR-ES,ECS Diagnostic X-ray System ]

• 08800011121914: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121907: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121891: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121884: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121877: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121808: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121792: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121785: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121778: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121761: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121679: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121662: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121655: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I
• 08800011121648: The DRGME’s directive DR-QP-0708-03_DI code assignment specifies that the UDI (Unique Device I