Sirius MRI Marker NS

GUDID 00863593000228

The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

C4 IMAGING, LLC

Brachytherapy source spacer

• Primary Device ID: 00863593000228
• NIH Device Record Key: c399f0e4-5aed-4361-afdf-a94b93c66e12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sirius MRI Marker NS
• Version Model Number: F-01-01-0011
• 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	00863593000228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171487

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00863593000228]

Radiation Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-15

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: 2018-07-12 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: 2018-07-06The SIRIUS MRI Marker NS is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy sources containing one of the following isotopes: Iodine 125 (125I), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.
• 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