Vaginal CT/MR Multi Channel Applicator

GUDID 08717213054356

Catheter with collar 6Fx293

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213054356
• NIH Device Record Key: b9f94ac4-3366-49e7-94d3-f099dc700f10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vaginal CT/MR Multi Channel Applicator
• Version Model Number: 110802-01
• 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: 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

Device Dimensions

• Length: 293 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213053724 [Primary]
GS1	08717213054356 [Package]; Contains: 08717213053724; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111973

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: 2020-02-06
• Device Publish Date: 2020-01-29

On-Brand Devices [Vaginal CT/MR Multi Channel Applicator]

• 08717213054356: Catheter with collar 6Fx293
• 08717213056817: VAGINAL CT/MR MULTI CHANNEL APPLICATOR SET