Plastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin GM11014710

GUDID 20810563021961

Varian Medical Systems Deutschland GmbH

Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle Brachytherapy needle
Primary Device ID20810563021961
NIH Device Record Keya9508d29-5fa2-495a-a87e-1819f3b802fb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastic needle MR safe, 2.0 mm diameter x 200 mm length, with mandrin
Version Model NumberGM11014710
Catalog NumberGM11014710
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810563021967 [Primary]
GS110810563021964 [Package]
Contains: 00810563021967
Package: [10 Units]
In Commercial Distribution
GS120810563021961 [Package]
Contains: 10810563021964
Package: [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


[20810563021961]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-26
Device Publish Date2024-02-16

Devices Manufactured by Varian Medical Systems Deutschland GmbH

10816389024646 - Flexible implant tube, double leader, 530 mm, sterile, set of 32024-04-19
10816389020310 - Transfer Guide Tube + for 320 mm applicators2024-02-28
10816389020327 - Transfer Guide Tube + of 1000 mm length for applicators2024-02-28
10816389020334 - Transfer Guide Tube + for 200 mm catheters2024-02-28
00816389020344 - Transfer Guide Tube + for 250 mm catheters2024-02-28
10816389020358 - Transfer Guide Tube + of 500 mm length for catheters2024-02-28
20816389020362 - Transfer Guide Tube + of 1000 mm length for catheters2024-02-28
10816389020372 - Transfer Guide Tube + of 1000 mm length for Luer connections2024-02-28

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