Catheter flap 200 mm x 290 mm x 10 mm, 40 channels GM11003910

GUDID 00816389022935

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389022935
NIH Device Record Keyaf2cad3b-68b1-4a6a-8ef0-5a27713207cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCatheter flap 200 mm x 290 mm x 10 mm, 40 channels
Version Model NumberGM11003910
Catalog NumberGM11003910
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389022935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389022935]

Moist Heat or Steam Sterilization


[00816389022935]

Moist Heat or Steam Sterilization


[00816389022935]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-23

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators2024-02-28
10816389020334 - Transfer Guide Tube + for 200 mm catheters2024-02-28
00816389020344 - Transfer Guide Tube + for 250 mm catheters2024-02-28
10816389020358 - Transfer Guide Tube + of 500 mm length for catheters2024-02-28
20816389020362 - Transfer Guide Tube + of 1000 mm length for catheters2024-02-28
10816389020372 - Transfer Guide Tube + of 1000 mm length for Luer connections2024-02-28

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