Transfer Guide Tube + for 200 mm catheters GM11014630

GUDID 10816389020334

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID10816389020334
NIH Device Record Keyabed73ba-4bac-4378-9ce9-717238d7649d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTransfer Guide Tube + for 200 mm catheters
Version Model NumberGM11014630
Catalog NumberGM11014630
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 Datetrue
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
GS100816389020337 [Primary]
GS110816389020334 [Package]
Contains: 00816389020337
Package: [8 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 Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-28
Device Publish Date2024-02-20

Devices Manufactured by Varian Medical Systems Deutschland GmbH

00816389028067 - Catheter Surface Flap Applicator Set2024-11-13
00816389028074 - Catheter flap, 200 mm x 290 mm x 10 mm2024-11-13
00810563021929 - Heyman capsule MR safe, 4 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563021936 - Heyman capsule MR safe, 6 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563021943 - Heyman capsule MR safe, 8 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563022834 - Intraluminal Applicator Set2024-10-08 Intraluminal Applicator Set
10816389027180 - Protection caps, blue (pack of 20)2024-05-03
10816389027210 - Sterilization plug, black (pack of 25)2024-05-03

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