Bite protector, 8 mm diameter (with strap) GM11007450

GUDID 00816389024182

Varian Medical Systems Deutschland GmbH

Oesophagus brachytherapy system applicator, remote-afterloading
Primary Device ID00816389024182
NIH Device Record Key40fe322d-bfef-41e6-bb5e-d7894a82c779
Commercial Distribution StatusIn Commercial Distribution
Brand NameBite protector, 8 mm diameter (with strap)
Version Model NumberGM11007450
Catalog NumberGM11007450
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 Datetrue
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
GS100816389024182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389024182]

Moist Heat or Steam Sterilization


[00816389024182]

Moist Heat or Steam Sterilization


[00816389024182]

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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