Sirius MRI Marker F-01-01-0001

GUDID 00863593000211

The SIRIUS MRI Marker 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: 00863593000211
• NIH Device Record Key: e45b98bb-05d2-4353-ad95-95dc7da42655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sirius MRI Marker
• Version Model Number: F-01-01-0001
• Catalog Number: F-01-01-0001
• Company DUNS: 003065466
• Company Name: C4 IMAGING, LLC
• Device Count: 1
• DM Exempt: true
• 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

Customer Support Contacts

• Phone: 713-280-1843
• Email: abright@c4imaging.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863593000211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131689

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00863593000211]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-21

On-Brand Devices [Sirius MRI Marker]

• 00863593000211: The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction wit
• 00863593000204: The SIRIUS MRI Marker is a component device indicated as an accessory for use in conjunction wit