GUDID 08717213052758

Oncentra External Beam Oncentra Brachy v4.6.1

Nucletron B.V.

Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software Radiation therapy software

• Primary Device ID: 08717213052758
• NIH Device Record Key: b2b94d2d-e493-4b91-8f67-865b4abf8488
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 170607-00
• 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
• 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
• 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	08717213052758 [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: 2021-10-20
• Device Publish Date: 2021-10-12

Devices Manufactured by Nucletron B.V.

• 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
• 08717213057760 - Esteya: 2022-08-24 Esteya
• 08717213056947 - NA: 2022-07-08 INSERTION TOOL
• 08717213008991 - X-ray Catheters: 2022-06-10 X-Ray Catheter Set Standard USA GYN SS
• 08717213009387 - X-ray Catheters: 2022-06-10 GYN X-Ray Catheter Set (channel 1-3)