Brilliance CT Big Bore

GUDID 00884838059450

Philips Medical Systems Nederland B.V.

Full-body CT system

• Primary Device ID: 00884838059450
• NIH Device Record Key: abcc26b2-9038-44d0-9763-1b8411c674a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Brilliance CT Big Bore
• Version Model Number: 728244
• 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	00884838059450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033357

FDA Product Code

• JAK: System, x-ray, tomography, computed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-03
• Device Publish Date: 2016-09-23

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838118454 - Philips: 2024-07-26 MRI Needle Block 8G
• 00884838118461 - Philips: 2024-07-26 Fiducial Marker Sleeve Assembly
• 00884838118478 - Philips: 2024-07-26 FIDUCIAL MARKER GRID BLOCK ASSEMBLY
• 00884838118485 - Philips: 2024-07-26 MRI Needle Block 12G
• 00884838118492 - Philips: 2024-07-26 MRI Needle Block 14G
• 00884838118508 - Philips: 2024-07-26 MRI Needle Block 16G
• 00884838118515 - Philips: 2024-07-26 MRI Needle Block 18G
• 00884838118522 - Philips: 2024-07-26 MRI Needle Sleeve 12G