Sentinel

GUDID 07350005280017

C-Rad Positioning AB

Laser patient positioning system

• Primary Device ID: 07350005280017
• NIH Device Record Key: ca8ff51e-7367-401b-b703-933fa9ed05bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentinel
• Version Model Number: SP001
• Company DUNS: 509296997
• Company Name: C-Rad Positioning AB
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350005280017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120668

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2016-09-22

Devices Manufactured by C-Rad Positioning AB

• 17350005280038 - Catalyst+: 2020-07-24
• 17350005280045 - Catalyst+: 2020-07-24
• 17350005280052 - HIT Laser: 2020-07-24 Laser Box Product Number: HW004 laser Product number: HW049
• 17350005280069 - HIT laser: 2020-07-24 Laser Box Product Number: HW004 laser Product number: HW050
• 17350005280076 - HIT Laser: 2020-07-24 Laser Box Product Number: HW006 laser Product number: HW049
• 17350005280083 - HIT Laser: 2020-07-24 Laser Box Product Number: HW006 laser Product number: HW050
• 17350005280090 - HIT Laser: 2020-07-24 Laser Box Product Number: HW002 laser Product number: HW049, HW050
• 17350005280106 - HIT Laser: 2020-07-24 Laser Box Product Number: HW002 laser Product number: HW049