Applicator Needle

GUDID 00812444027310

Brachytherapy

RIVERPOINT MEDICAL, LLC

Brachytherapy needle
Primary Device ID00812444027310
NIH Device Record Key8a0988cb-59b5-4e6d-ac26-40e0613f8953
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator Needle
Version Model Number1100-1812X
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812444027310 [Primary]
GS110812444027317 [Package]
Package: [5 Units]
In Commercial Distribution
GS120812444027314 [Package]
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-24
Device Publish Date2017-11-02

Devices Manufactured by RIVERPOINT MEDICAL, LLC

10840277405774 - Vilet II2024-11-12 Suture
10840277405781 - Vilet II2024-11-12 Suture
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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