Brachytherapy Guide Needle

GUDID 00812444027143

Brachytherapy

RIVERPOINT MEDICAL, LLC

Brachytherapy needle
Primary Device ID00812444027143
NIH Device Record Key66dc9929-77fe-40d3-ae70-0c0b9ef88aa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBrachytherapy Guide Needle
Version Model NumberIBGN001
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812444027143 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-02

Devices Manufactured by RIVERPOINT MEDICAL, LLC

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10840277405354 - Vilet II2024-11-11 Suture
10840277405736 - Vilet II2024-11-11 Suture
00840277405746 - Vilet II2024-11-11 Suture
10840277405750 - Vilet II2024-11-11 Suture
10840277405767 - Vilet II2024-11-11 Suture
00840277405968 - ARTHROLINK2024-11-07 Suture

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