APELEM

GUDID 03760172650430

Remote controlled radiology system

APELEM

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• Primary Device ID: 03760172650430
• NIH Device Record Key: ea6b6585-e8f8-4f38-b03e-afd0445a3221
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APELEM
• Version Model Number: Persona RF PREMIUM
• Company DUNS: 268596533
• Company Name: APELEM
• 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	03760172650430 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203010

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2022-04-20
• Device Publish Date: 2022-04-12

On-Brand Devices [APELEM]

• 03760172650430: Remote controlled radiology system
• 03760172650003: Remote controlled radiology system
• 03760172650508: Remote Controlled Radiology System
• 03760172650485: Remote Controlled Radiology System
• 03760172650447: Remote controlled Radiology System
• 03760172650409: Remote Controlled Radiology System