HDR MRI Lumen Marker

GUDID 00863593000235

The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length. The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators.

C4 IMAGING, LLC

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• Primary Device ID: 00863593000235
• NIH Device Record Key: eafb81a8-9593-417c-961b-ed1fba8fe6fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HDR MRI Lumen Marker
• Version Model Number: F-01-02-0001
• Company DUNS: 003065466
• Company Name: C4 IMAGING, LLC
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863593000235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180069

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-12
• Device Publish Date: 2018-06-11

Devices Manufactured by C4 IMAGING, LLC

• 00863593000273 - Nova 10 Fiducial Marker: 2022-05-03
• 00863593000242 - Nova 5: 2021-09-13 The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobal
• 00863593000259 - Nova 5: 2021-09-13 The Fiducial Marker consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a solution of up to 1.0% cobal
• 00863593000235 - HDR MRI Lumen Marker: 2018-07-12The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline solution. The HDPE tube is up to 350.0 mm in length and 1.0 mm in diameter, with the distal 19.0 mm of the tube accommodating a HDPE sealing plug. The distal end of the device is provided with an attached HDPE end-cap for handling. This end cap is approximately 3.0 mm in length. The HDR MRI Lumen Marker is an accessory to remote controlled high dose rate (HDR) radionuclide applicator systems and facilitates the identification of lumens within MRI compatible HDR brachytherapy applicators.
• 00863593000235 - HDR MRI Lumen Marker: 2018-07-12 The HDR MRI Lumen Marker is a sealed high-density polyethylene (HDPE) tube containing a cobalt chloride N-Acetylcysteine saline
• 00863593000204 - Sirius MRI Marker: 2018-07-06 The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sle
• 00863593000211 - Sirius MRI Marker: 2018-07-06 The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sle
• 00863593000228 - Sirius MRI Marker NS: 2018-07-06 The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier