Allura Xper FD 722022

GUDID 00884838059078

Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-inch flat detector and interface for an OR table

Philips Medical Systems Nederland B.V.

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• Primary Device ID: 00884838059078
• NIH Device Record Key: 77cc4d6a-9e66-4b1c-9585-6b184d7b1d86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allura Xper FD
• Version Model Number: Allura Xper FD10 OR Table
• Catalog Number: 722022
• Company DUNS: 413819707
• Company Name: Philips Medical Systems Nederland B.V.
• 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	00884838059078 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130638

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-09-20
• Device Publish Date: 2016-09-24

On-Brand Devices [Allura Xper FD]

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• 00884838059092: Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch flat detector), ce
• 00884838059085: Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 20-inch flat de
• 00884838059078: Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-inch flat de
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• 00884838059054: Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
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• 00884838054240: Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 20-inch flat de
• 00884838054233: Monoplane Interventional X-Ray System. A ceiling-mounted monoplane system with a 10-inch flat de
• 00884838054226: Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector) and
• 00884838054219: Biplane Interventional X-Ray System with floor-mounted frontal stand (20-inch flat detector) and
• 00884838054202: Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 20-inc
• 00884838054196: Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch flat detector) and
• 00884838054189: Monoplane Interventional X-Ray System. A ceiling or floor-mounted monoplane system with a 10-inc