Luneray

GUDID 08717213054387

Catheter 6F 50cm, needle 57mm R60mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213054387
• NIH Device Record Key: ecb21838-58fb-41d3-bb37-c521842cdcab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luneray
• Version Model Number: 110562-01
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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
• 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 Dimensions

• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter
• Length: 57 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213054073 [Primary]
GS1	08717213054387 [Package]; Contains: 08717213054073; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140803

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: 2022-11-23
• Device Publish Date: 2022-11-15

On-Brand Devices [Luneray]

• 08717213054394: Catheter 6F 50cm, needle 67mm R75mm
• 08717213054387: Catheter 6F 50cm, needle 57mm R60mm
• 08717213054370: Catheter 6F 50cm, needle 47mm R45mm
• 08717213054363: Catheter 6F 50cm, needle 37mm R30mm