Flexible implant tube, double leader, 530 mm, sterile, set of 3 GM11008570

GUDID 10816389024646

Varian Medical Systems Deutschland GmbH

Tongue brachytherapy system applicator, remote-afterloading
Primary Device ID10816389024646
NIH Device Record Keye055372a-5419-4c1b-a58a-7f93b5f65135
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible implant tube, double leader, 530 mm, sterile, set of 3
Version Model NumberGM11008570
Catalog NumberGM11008570
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count3
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter
Length530 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389024649 [Unit of Use]
GS110816389024646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-04-19
Device Publish Date2016-09-23

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