Flexible Implant Tubes

GUDID 08717213054189

Radiopaque Button, black 1.9 mm

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213054189
• NIH Device Record Key: da13f8a8-1be7-4821-bfd5-3dada20707e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Implant Tubes
• Version Model Number: 189285-01
• Company DUNS: 415269930
• Company Name: Nucletron B.V.
• Device Count: 6
• 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

• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213053328 [Unit of Use]
GS1	08717213053342 [Primary]
GS1	08717213054189 [Package]; Contains: 08717213053342; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032372

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: 2020-06-29
• Device Publish Date: 2020-06-20

On-Brand Devices [Flexible Implant Tubes]

• 08717213054219: Radiopaque Button, green 1.9 mm
• 08717213054202: Radiopaque Button, blue 1.9 mm
• 08717213054189: Radiopaque Button, black 1.9 mm
• 08717213054196: Radiopaque Button, red 1.9 mm
• 08717213054158: Flexible Implant Tubes Set, 6F, DL, 30cm
• 08717213055230: Flexible Implant Tubes Set, 6F, SL, 30cm
• 08717213054165: Flexible Implant Tube 5F, DL, 30cm
• 08717213055254: Flexible Implant Tube 5F, SL, 30cm
• 08717213054172: Radiopaque Button, white 1.9 mm
• 08717213054240: Radiopaque Button, white 1.7 mm
• 08717213054301: Radiopaque Button, brown 1.7 mm
• 08717213054295: Radiopaque Button, yellow 1.7 mm
• 08717213054288: Radiopaque Button, green 1.7 mm
• 08717213054271: Radiopaque Button, blue 1.7 mm
• 08717213054264: Radiopaque Button, red 1.7 mm
• 08717213054257: Radiopaque Button, black 1.7 mm
• 08717213054233: Radiopaque Button, brown 1.9 mm
• 08717213054226: Radiopaque Button, yellow 1.9 mm