GUDID 08717213056947

INSERTION TOOL

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213056947
• NIH Device Record Key: cdf1e145-1652-4cc8-91ab-dbec4ea21e04
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 189714P01-03
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: true
• Device Kit: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com
• Phone: 7703009725
• Email: info.america@elekta.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213056947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091154

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

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

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

[08717213056947]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-08
• Device Publish Date: 2022-06-30

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: 2022-07-08INSERTION TOOL
• 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)