Triple plane templates, 10 mm hole separation, 8 holes across bottom width AL07349012

GUDID 00816389020641

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389020641
NIH Device Record Key3da85e9c-ca28-4035-a0e1-8f87fd7d5592
Commercial Distribution StatusIn Commercial Distribution
Brand NameTriple plane templates, 10 mm hole separation, 8 holes across bottom width
Version Model NumberAL07349012
Catalog NumberAL07349012
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389020641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389020641]

Moist Heat or Steam Sterilization


[00816389020641]

Moist Heat or Steam Sterilization


[00816389020641]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-19

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