Pushing device for implant needle, 2.2 mm diameter GM11002820

GUDID 00816389022331

for Flexible Interstitial Implant Tube Set, plus GM11008570-8580

VARIAN MEDICAL SYSTEMS, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00816389022331
NIH Device Record Key78db1bf2-890e-479f-b134-7f638dae2fc4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePushing device for implant needle, 2.2 mm diameter
Version Model NumberGM11002820
Catalog NumberGM11002820
Company DUNS009120817
Company NameVARIAN MEDICAL SYSTEMS, INC.
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 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 Identifiers

Device Issuing AgencyDevice ID
GS100816389022331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAQSystem, applicator, radionuclide, remote-controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


[00816389022331]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-10
Device Publish Date2021-02-02

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