ClarifEye 002120

GUDID 00884838104570

Software medical device. Intended for use by professional healthcare providers as an intra-operative image-guidance tool used during surgical and interventional therapy.

Philips Medical Systems Nederland B.V.

Stereotactic system application software

• Primary Device ID: 00884838104570
• NIH Device Record Key: 44bd25c7-1f5f-48b9-b9cb-85db88f9a115
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClarifEye
• Version Model Number: ClarifEye - 1
• Catalog Number: 002120
• 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: true
• Serial Number: false
• 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	00884838104570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201743

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-22
• Device Publish Date: 2021-03-12

Devices Manufactured by Philips Medical Systems Nederland B.V.

• 00884838119277 - Philips Sentinelle: 2024-12-25 dS 1.5T Interface Box
• 00884838119284 - Philips Sentinelle: 2024-12-25 dS 3.0T Interface Box
• 00884838119291 - Philips Sentinelle: 2024-12-25 dS 1.5T 8CH Medial
• 00884838119307 - Philips Sentinelle: 2024-12-25 dS 3.0T 8CH Medial
• 00884838119314 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Left
• 00884838119321 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Left
• 00884838119338 - Philips Sentinelle: 2024-12-25 dS 1.5T 4CH Lateral Right
• 00884838119345 - Philips Sentinelle: 2024-12-25 dS 3.0T 4CH Lateral Right