Cervical Sleeve IU 6.4mm diameter, 60mm diameter, without marker GM11010580

GUDID 00816389025455

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389025455
NIH Device Record Keye918d019-6a10-44ef-840e-17af9af7ee4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervical Sleeve IU 6.4mm diameter, 60mm diameter, without marker
Version Model NumberGM11010580
Catalog NumberGM11010580
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

Length60 Millimeter
Length60 Millimeter
Length60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389025455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389025455]

Moist Heat or Steam Sterilization


[00816389025455]

Moist Heat or Steam Sterilization


[00816389025455]

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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