Monofil, 0.8mm diameter, for bronchial catheter, sterile GM11006270

GUDID 00816389023789

Varian Medical Systems Deutschland GmbH

Brachytherapy system remote afterloading source transfer tube
Primary Device ID00816389023789
NIH Device Record Keyb0f4d94a-a857-4c48-a884-dfae722d5dcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMonofil, 0.8mm diameter, for bronchial catheter, sterile
Version Model NumberGM11006270
Catalog NumberGM11006270
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
GS100816389023789 [Primary]
GS110816389023786 [Package]
Package: [5 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

Devices Manufactured by Varian Medical Systems Deutschland GmbH

00810563022346 - Titanium Fletcher style Applicator Set Defined Geometry2024-11-27
00810563022421 - Smit cervical sleeves ø 3 mm, 30mm length, with marker2024-11-27
00810563022438 - Smit cervical sleeves ø 3 mm, 40mm length, with marker2024-11-27
00810563022445 - Smit cervical sleeves ø 3 mm, 50mm length, with marker2024-11-27
00810563022452 - Smit cervical sleeves ø 3 mm, 60mm length, with marker2024-11-27
00810563022469 - Smit cervical sleeves ø 3 mm, 70mm length, with marker2024-11-27
00810563022476 - Smit cervical sleeves ø 3 mm, 80mm length, with marker2024-11-27
00810563022483 - Fixation for 3 channel applicators, for adjustable holder2024-11-27

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.