CT/MR OncoSmart Catheter System

GUDID 08717213055278

Comfort Flexibles Set CT

Nucletron B.V.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID08717213055278
NIH Device Record Key1682a8a4-1979-48f9-864a-768e4a21f549
Commercial Distribution StatusIn Commercial Distribution
Brand NameCT/MR OncoSmart Catheter System
Version Model Number189844-01
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone+1(770)300-9725
Emailinfo.america@elekta.com

Device Dimensions

Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213055278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-29
Device Publish Date2020-06-20

On-Brand Devices [CT/MR OncoSmart Catheter System]

08717213055278Comfort Flexibles Set CT
08717213055261Flexible Implant Tube Set CT (SL)
08717213055247CT/MR Flexible Implant Tube Set (SL)
08717213055223CT/MR OncoSmart Catheter Set, 6F, 30cm, SL
08717213055469CT/MR OncoSmart Catheter Set, 200mm
08717213055452CT/MR OncoSmart Catheter Set (18 Ch), 240mm
08717213055445CT/MR OncoSmart Catheter Set (30 Ch), 240mm
08717213055490CT/MR OncoSmart Catheter Set, Large, white (30 Ch)
08717213055483CT/MR OncoSmart Catheter Set, 294mm
08717213055476CT/MR OncoSmart Catheter Set, 240mm

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