Open CT vaginal-cylinder, 26 mm diameter, length 140 mm GM11005290

GUDID 00816389023611

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389023611
NIH Device Record Key31e7dd49-9e1e-415f-b0d9-b475c0310142
Commercial Distribution StatusIn Commercial Distribution
Brand NameOpen CT vaginal-cylinder, 26 mm diameter, length 140 mm
Version Model NumberGM11005290
Catalog NumberGM11005290
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 Dimensions

Outer Diameter26 Millimeter
Outer Diameter26 Millimeter
Outer Diameter26 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389023611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389023611]

Moist Heat or Steam Sterilization


[00816389023611]

Moist Heat or Steam Sterilization


[00816389023611]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-22

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