CT/MR OncoSmart Catheter System

GUDID 08717213055278

Comfort Flexibles Set CT

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213055278
• NIH Device Record Key: 1682a8a4-1979-48f9-864a-768e4a21f549
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CT/MR OncoSmart Catheter System
• Version Model Number: 189844-01
• Company DUNS: 415269930
• Company Name: Nucletron 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(770)300-9725
• Email: info.america@elekta.com

Device Dimensions

• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213055278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032372

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-29
• Device Publish Date: 2020-06-20

On-Brand Devices [CT/MR OncoSmart Catheter System]

• 08717213055278: Comfort Flexibles Set CT
• 08717213055261: Flexible Implant Tube Set CT (SL)
• 08717213055247: CT/MR Flexible Implant Tube Set (SL)
• 08717213055223: CT/MR OncoSmart Catheter Set, 6F, 30cm, SL
• 08717213055469: CT/MR OncoSmart Catheter Set, 200mm
• 08717213055452: CT/MR OncoSmart Catheter Set (18 Ch), 240mm
• 08717213055445: CT/MR OncoSmart Catheter Set (30 Ch), 240mm
• 08717213055490: CT/MR OncoSmart Catheter Set, Large, white (30 Ch)
• 08717213055483: CT/MR OncoSmart Catheter Set, 294mm
• 08717213055476: CT/MR OncoSmart Catheter Set, 240mm