Martinez Prostate Template

GUDID 08717213031951

Template Holder for OncoSelect stepper

Nucletron B.V.

Prostate brachytherapy system applicator, remote-afterloading
Primary Device ID08717213031951
NIH Device Record Keyc2be72ac-4e81-4a1e-888a-ab14645437f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMartinez Prostate Template
Version Model Number137949-03
Company DUNS415269930
Company NameNucletron B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS108717213031951 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717213031951]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-02
Device Publish Date2019-09-24

On-Brand Devices [Martinez Prostate Template]

08717213031951Template Holder for OncoSelect stepper
08717213031913Template Holder, AccuSeed Stepper
08717213055179Template Holder for OncoSelect stepper
08717213055162Template Holder for RTP Stepper
08717213055155Template Holder, OncoSelect Stepper
08717213055148Template Holder, RTP Stepper
08717213054936Holder Ring RTP

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