Bronchial catheter, 5 Fr, sterile, GammaMedplus GM11000530

GUDID 00816389021587

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389021587
NIH Device Record Key1574811b-d908-4432-a367-bb04919e0f64
Commercial Distribution StatusIn Commercial Distribution
Brand NameBronchial catheter, 5 Fr, sterile, GammaMedplus
Version Model NumberGM11000530
Catalog NumberGM11000530
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100816389021587 [Primary]
GS110816389021584 [Package]
Package: [5 Units]
In Commercial Distribution
GS120816389021581 [Package]
Contains: 10816389021584
Package: [10 Units]
In Commercial Distribution

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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