Fletcher CT/MR Shielded Applicator

GUDID 08717213024298

Fixation Clip

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213024298
• NIH Device Record Key: 269c17c6-a71a-4a37-b77e-6cfcd8e332ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fletcher CT/MR Shielded Applicator
• Version Model Number: 110957-00
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213024298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132889

FDA Product Code

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

Sterilization

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

[08717213024298]

Hydrogen Peroxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-30
• Device Publish Date: 2019-09-21

On-Brand Devices [Fletcher CT/MR Shielded Applicator]

• 08717213024441: Cervical Stopper (6 mm)
• 08717213024298: Fixation Clip
• 08717213024342: Cervical Stopper (4 mm)