Intrauterine tandem for 90 degree ring, 70mm GM11011360

GUDID 00816389026100

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389026100
NIH Device Record Keyfa5063a0-a4a2-4162-9663-e6de2b5506c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntrauterine tandem for 90 degree ring, 70mm
Version Model NumberGM11011360
Catalog NumberGM11011360
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

Length70 Millimeter
Length70 Millimeter
Length70 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389026100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389026100]

Moist Heat or Steam Sterilization


[00816389026100]

Moist Heat or Steam Sterilization


[00816389026100]

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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