ProxiGiagnost N90 706100

GUDID 00884838085619

Image-intensified fluoroscopic x-ray system

Philips Medical Systems DMC GmbH

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• Primary Device ID: 00884838085619
• NIH Device Record Key: 86b3d965-bae0-4263-be64-5335000cf65a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProxiGiagnost N90
• Version Model Number: 9890-010-70221
• Catalog Number: 706100
• Company DUNS: 314101218
• Company Name: Philips Medical Systems DMC GmbH
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx
• Phone: +1(800)722-9377
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838085619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173433

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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-09

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• 00884838097339 - Anti-scatter Grid (60/10/110): 2024-01-26
• 00884838105454 - CT4000: 2023-09-08 diagnostic x-ray tube housing assembly
• 00884838113749 - XS-100 X-Ray Tube Assembly: 2023-09-08 Diagnostic x-ray tube housing assembly
• 00884838121379 - CT3000: 2023-09-08 Diagnostic x-ray tube housing assembly
• 00884838121386 - CT4000: 2023-09-08 Diagnostic x-ray tube housing assembly
• 00884838097506 - Anti-scatter Grid (36/12/100): 2023-08-14