Source guide tube light with locking mechanism for 320 mm needles, GammaMedplus GM11010760

GUDID 00816389025622

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389025622
NIH Device Record Keybfd062bf-1fed-4620-9ed0-5313a736288d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSource guide tube light with locking mechanism for 320 mm needles, GammaMedplus
Version Model NumberGM11010760
Catalog NumberGM11010760
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
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 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
GS100816389025622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


[00816389025622]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-09
Device Publish Date2021-02-01

Devices Manufactured by VARIAN MEDICAL SYSTEMS, INC.

00856100006158 - Visual Coaching Device (VCD)2023-11-22
00850800006067 - VariSeed2023-09-25
00858086006801 - IDENTIFY2023-08-14
00855141006202 - Eclipse Treatment Planning System2023-08-07
00899475002042 - Clinac iX2023-06-20
00899475002066 - Trilogy2023-06-20
00899475002080 - Novalis Tx2023-06-20
00810563021066 - Embozene Color Advance 40um Embozene 2mL Colored - US2023-05-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.