Brachytherapy

GUDID 30812444028875

Brachytherapy needle

RIVERPOINT MEDICAL, LLC

Brachytherapy needle
Primary Device ID30812444028875
NIH Device Record Key0aa69549-2f34-4d16-aa1d-f2654165e93f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrachytherapy
Version Model NumberGM1052-S5-1820
Company DUNS964053560
Company NameRIVERPOINT MEDICAL, LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812444028874 [Primary]
GS110812444028871 [Package]
Contains: 00812444028874
Package: [5 Units]
In Commercial Distribution
GS120812444028878 [Package]
Contains: 00812444028874
Package: [9 Units]
In Commercial Distribution
GS130812444028875 [Package]
Contains: 00812444028874
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-05
Device Publish Date2018-10-03

On-Brand Devices [Brachytherapy]

30812444028929BRACHYTHERAPY
30812444028875Brachytherapy needle
00812444024975BRACHYTHERAPY
00812444024968BRACHYTHERAPY
00812444024951BRACHYTHERAPY
00812444024944BRACHYTHERAPY
00812444024937BRACHYTHERAPY
30812444028998Brachytherapy Needle
20812444029257Brachytherapy

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