Martinez Prostate Template

GUDID 08717213055155

Template Holder, OncoSelect Stepper

Nucletron B.V.

Prostate brachytherapy system applicator, remote-afterloading

• Primary Device ID: 08717213055155
• NIH Device Record Key: 23935581-56e7-48df-b5e4-2d4abe1b133d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Martinez Prostate Template
• Version Model Number: 137949P01-04
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717213055155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142439

FDA Product Code

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

Sterilization

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

[08717213055155]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-28
• Device Publish Date: 2019-10-19

On-Brand Devices [Martinez Prostate Template]

• 08717213031951: Template Holder for OncoSelect stepper
• 08717213031913: Template Holder, AccuSeed Stepper
• 08717213055179: Template Holder for OncoSelect stepper
• 08717213055162: Template Holder for RTP Stepper
• 08717213055155: Template Holder, OncoSelect Stepper
• 08717213055148: Template Holder, RTP Stepper
• 08717213054936: Holder Ring RTP