Ear, nose & throat mould without balloons, with two guide tubes, sterile GM11003320

GUDID 00816389022546

Varian Medical Systems Deutschland GmbH

Nasopharynx brachytherapy system applicator, remote-afterloading
Primary Device ID00816389022546
NIH Device Record Keyac876382-d2b8-4676-9d90-ec012d552c51
Commercial Distribution StatusIn Commercial Distribution
Brand NameEar, nose & throat mould without balloons, with two guide tubes, sterile
Version Model NumberGM11003320
Catalog NumberGM11003320
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389022546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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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