Cervical Sleeve IU 6.4 mm diameter, 70mm diameter, with marker GM11011390

GUDID 00816389026131

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389026131
NIH Device Record Keye0b56f1c-4ffb-4c95-af4d-01800660d813
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervical Sleeve IU 6.4 mm diameter, 70mm diameter, with marker
Version Model NumberGM11011390
Catalog NumberGM11011390
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

Length70 Millimeter
Length70 Millimeter
Length70 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389026131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389026131]

Moist Heat or Steam Sterilization


[00816389026131]

Moist Heat or Steam Sterilization


[00816389026131]

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

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