Esophagus bougie diameter 10 mm, with bite protector and fixation GM11007420

GUDID 00816389024151

Varian Medical Systems Deutschland GmbH

Oesophagus brachytherapy system applicator, remote-afterloading
Primary Device ID00816389024151
NIH Device Record Keyf62c722c-f1d1-4572-81df-4477c6ca30d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsophagus bougie diameter 10 mm, with bite protector and fixation
Version Model NumberGM11007420
Catalog NumberGM11007420
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 Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389024151 [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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