Fletcher CT/MR Shielded Applicator

GUDID 08717213024298

Fixation Clip

Nucletron B.V.

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID08717213024298
NIH Device Record Key269c17c6-a71a-4a37-b77e-6cfcd8e332ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameFletcher CT/MR Shielded Applicator
Version Model Number110957-00
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS108717213024298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717213024298]

Hydrogen Peroxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-30
Device Publish Date2019-09-21

On-Brand Devices [Fletcher CT/MR Shielded Applicator]

08717213024441Cervical Stopper (6 mm)
08717213024298Fixation Clip
08717213024342Cervical Stopper (4 mm)

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