4.7 Fr. metal-tipped catheter, 150 cm AL13114000

GUDID 00816389021273

Varian Medical Systems Deutschland GmbH

General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00816389021273
NIH Device Record Key65b9cafc-80fc-454f-aa6d-85a1ad4f6cdd
Commercial Distribution StatusIn Commercial Distribution
Brand Name4.7 Fr. metal-tipped catheter, 150 cm
Version Model NumberAL13114000
Catalog NumberAL13114000
Company DUNS332474605
Company NameVarian Medical Systems Deutschland GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Length150 Centimeter
Length150 Centimeter
Length150 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100816389021273 [Primary]
GS110816389021270 [Package]
Package: Pack [10 Units]
In Commercial Distribution
GS120816389021277 [Package]
Package: Pack [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

[00816389021273]

Moist Heat or Steam Sterilization


[00816389021273]

Moist Heat or Steam Sterilization


[00816389021273]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-02-07
Device Publish Date2016-09-19

Devices Manufactured by Varian Medical Systems Deutschland GmbH

10816389027180 - Protection caps, blue (pack of 20)2024-05-03
10816389027210 - Sterilization plug, black (pack of 25)2024-05-03
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

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