← Back to catalogue

Sirius MRI Marker

FDA UDI

Class II (US FDA UDI)

by C4 Imaging Llc

Identity

Trade Name
Sirius MRI Marker FDA UDI
Generic Name
Brachytherapy source spacer FDA UDI
Device Name
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. FDA UDI
Model / Reference
C-01-99-0014 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
F-01-01-0001 FDA UDI
Primary DI / UDI-DI
00863593000204 FDA UDI
510(k) Number
K131689 FDA UDI
FDA Product Code
KXK FDA UDI
GMDN Term
Brachytherapy source spacer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5730 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Sirius MRI Marker by C4 Imaging Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K131689 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
C4 Imaging Llc

Sources (1)

  • FDA UDI 3194bd8e-af20-4414-8ff2-5d9f40a72aed 38 fields · synced May 29, 2026