GUDID 08717213058118

Oncentra Brachy

Nucletron B.V.

Radiation therapy software

• Primary Device ID: 08717213058118
• NIH Device Record Key: 9e3f873d-3144-418b-a8c9-926fe5b4feaf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 170730
• 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: 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213058118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121448

FDA Product Code

• MUJ: System, Planning, Radiation Therapy Treatment

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: 2025-11-21
• Device Publish Date: 2025-11-13

Devices Manufactured by Nucletron B.V.

• 08717213058118 - NA: 2025-11-21Oncentra Brachy
• 08717213058118 - NA: 2025-11-21 Oncentra Brachy
• 08717213060722 - Elekta Freiburg Flap: 2025-02-26
• 08717213057203 - Smit Sleeve: 2024-07-15 Sleeve CT/MR Intrauterine Tube
• 08717213057258 - Smit Sleeve: 2024-07-15 Smit Sleeve CT/MR, 4mm
• 08717213054363 - Luneray: 2022-11-23 Catheter 6F 50cm, needle 37mm R30mm
• 08717213054370 - Luneray: 2022-11-23 Catheter 6F 50cm, needle 47mm R45mm
• 08717213054387 - Luneray: 2022-11-23 Catheter 6F 50cm, needle 57mm R60mm
• 08717213054394 - Luneray: 2022-11-15 Catheter 6F 50cm, needle 67mm R75mm