Length cutting gauge, 320mm for implant tubes and breast applicators up to 6 Fr. GM11010040

GUDID 00816389025189

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389025189
NIH Device Record Keyfcb611f6-307a-4243-a3e2-0867a285c659
Commercial Distribution StatusIn Commercial Distribution
Brand NameLength cutting gauge, 320mm for implant tubes and breast applicators up to 6 Fr.
Version Model NumberGM11010040
Catalog NumberGM11010040
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length320 Millimeter
Length320 Millimeter
Length320 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389025189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389025189]

Moist Heat or Steam Sterilization


[00816389025189]

Moist Heat or Steam Sterilization


[00816389025189]

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

On-Brand Devices [Length cutting gauge, 320mm for implant tubes and breast applicators up to 6 Fr.]

00816389025189GM11010040
00816389029101GM11010040

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