declipse®SPECT SE 1301-0002

GUDID ESURSE13010002

SurgicEye GmbH

Scintillation radiation measuring probe

• Primary Device ID: ESURSE13010002
• NIH Device Record Key: 823cf8c0-460a-464e-86a9-f71f32cae389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: declipse®SPECT
• Version Model Number: declipseSPECT Viewer
• Catalog Number: SE 1301-0002
• Company DUNS: 340279325
• Company Name: SurgicEye 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4989549989050
• Email: support@surgiceye.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ESURSE13010002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123917

FDA Product Code

• IZD: Probe, Uptake, Nuclear

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-17