LumenCare Azure

GUDID 08717213056770

LumenCare Azure Set 5F, 140cm

Nucletron B.V.

Bronchial brachytherapy system applicator, remote-afterloading Bronchial brachytherapy system applicator, remote-afterloading Bronchial brachytherapy system applicator, remote-afterloading
Primary Device ID08717213056770
NIH Device Record Key87b82dc7-f72a-4d1d-acaa-d0dd36026f03
Commercial Distribution StatusIn Commercial Distribution
Brand NameLumenCare Azure
Version Model Number110691-02
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
Phone+1(770)300-9725
Emailinfo.america@elekta.com
Phone+1(770)300-9725
Emailinfo.america@elekta.com

Device Dimensions

Length140 Centimeter
Catheter Gauge5 French
Length140 Centimeter
Catheter Gauge5 French
Length140 Centimeter
Catheter Gauge5 French

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213056770 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-25
Device Publish Date2020-05-16

On-Brand Devices [LumenCare Azure]

08717213056770LumenCare Azure Set 5F, 140cm
08717213056763LumenCare Azure Set 5F, 150cm
08717213054332LumenCare Azure 5F, 150cm
08717213055735LumenCare Azure 5F, 140cm
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