Plastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin GM11010750

GUDID 00816389025615

for 320 mm needles(GM11003100)

Varian Medical Systems Deutschland GmbH

Brachytherapy needle Brachytherapy needle Brachytherapy needle
Primary Device ID00816389025615
NIH Device Record Keyddb7ca9b-1ae2-48d4-8a13-0fd2494b9892
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastic needle 2.0 mm diameter, 320 mm length, blunt tip w/ mandrin
Version Model NumberGM11010750
Catalog NumberGM11010750
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Length320 Millimeter
Length320 Millimeter
Length320 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389025615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389025615]

Moist Heat or Steam Sterilization


[00816389025615]

Moist Heat or Steam Sterilization


[00816389025615]

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

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.