Cervical Sleeve IU 6.4mm diameter, 60mm diameter, with marker GM11011380

GUDID 00816389026124

Varian Medical Systems Deutschland GmbH

Cervical/intrauterine brachytherapy system applicator, remote-afterloading
Primary Device ID00816389026124
NIH Device Record Keyc5d21a57-a227-4910-a393-89f7e2613949
Commercial Distribution StatusIn Commercial Distribution
Brand NameCervical Sleeve IU 6.4mm diameter, 60mm diameter, with marker
Version Model NumberGM11011380
Catalog NumberGM11011380
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
GS100816389026124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389026124]

Moist Heat or Steam Sterilization


[00816389026124]

Moist Heat or Steam Sterilization


[00816389026124]

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

Devices Manufactured by Varian Medical Systems Deutschland GmbH

00816389028067 - Catheter Surface Flap Applicator Set2024-11-13
00816389028074 - Catheter flap, 200 mm x 290 mm x 10 mm2024-11-13
00810563021929 - Heyman capsule MR safe, 4 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563021936 - Heyman capsule MR safe, 6 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563021943 - Heyman capsule MR safe, 8 mm diameter x 17.5 mm length, with mandrin2024-10-31
00810563022834 - Intraluminal Applicator Set2024-10-08 Intraluminal Applicator Set
10816389027180 - Protection caps, blue (pack of 20)2024-05-03
10816389027210 - Sterilization plug, black (pack of 25)2024-05-03

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