Sirius MRI Marker F-01-01-0001

GUDID 00863593000204

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 ID00863593000204
NIH Device Record Key3194bd8e-af20-4414-8ff2-5d9f40a72aed
Commercial Distribution Discontinuation2016-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSirius MRI Marker
Version Model NumberC-01-99-0014
Catalog NumberF-01-01-0001
Company DUNS003065466
Company NameC4 IMAGING, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone713-280-1843
Emailabright@c4imaging.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100863593000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00863593000204]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-02-19

On-Brand Devices [Sirius MRI Marker]

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

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