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: F-01-01-0001 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: 00863593000211 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Brachytherapy source spacer

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

Similar devices

Also classified as Brachytherapy source spacer.

SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
BrachySource™, SourceCap™ — BARD BRACHYTHERAPY, INC · Class II
Theragenics — THERAGENICS CORP. · Class II
QuickLink™, SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
TheraSeed®, SourceLink™ — BARD BRACHYTHERAPY, INC · Class II
Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk — Eckert & Ziegler BEBIG GmbH · Class I
BrachySource™ — BARD BRACHYTHERAPY, INC · Class II
TheraSeed®, SourceLink™ — BARD BRACHYTHERAPY, INC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: C4 Imaging Llc

Sources (1)

FDA UDI e45b98bb-05d2-4353-ad95-95dc7da42655 37 fields · synced Jun 8, 2026