Intrauterine tandem for 90 degree ring, 50mm GM11011340

GUDID 00816389026087

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389026087
NIH Device Record Key63225bbf-7f17-4d50-868a-5f4e7e23db3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntrauterine tandem for 90 degree ring, 50mm
Version Model NumberGM11011340
Catalog NumberGM11011340
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
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

Device Dimensions

Length50 Millimeter
Length50 Millimeter
Length50 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389026087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389026087]

Moist Heat or Steam Sterilization


[00816389026087]

Moist Heat or Steam Sterilization


[00816389026087]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-18

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