Esophagus bougie diameter 8 mm, with bite protector and fixation GM11007410

GUDID 00816389024144

Varian Medical Systems Deutschland GmbH

Oesophagus brachytherapy system applicator, remote-afterloading
Primary Device ID00816389024144
NIH Device Record Key11fbbdc3-1384-4b8b-9e03-b86bbba4f0d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsophagus bougie diameter 8 mm, with bite protector and fixation
Version Model NumberGM11007410
Catalog NumberGM11007410
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 Diameter8 Millimeter
Outer Diameter8 Millimeter
Outer Diameter8 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389024144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

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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