Cylinder segment, 25 mm diameter, length 30 mm GM11005100

GUDID 00816389023468

Varian Medical Systems Deutschland GmbH

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389023468
NIH Device Record Key1202be32-7a39-489f-9592-91e23afaf038
Commercial Distribution StatusIn Commercial Distribution
Brand NameCylinder segment, 25 mm diameter, length 30 mm
Version Model NumberGM11005100
Catalog NumberGM11005100
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 Usefalse
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 Dimensions

Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389023468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389023468]

Moist Heat or Steam Sterilization


[00816389023468]

Moist Heat or Steam Sterilization


[00816389023468]

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

Devices Manufactured by Varian Medical Systems Deutschland GmbH

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10816389027210 - Sterilization plug, black (pack of 25)2024-05-03
10816389024646 - Flexible implant tube, double leader, 530 mm, sterile, set of 32024-04-19
10816389020310 - Transfer Guide Tube + for 320 mm applicators2024-02-28
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

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