RIVERPONT BRACHYTHERAPY

GUDID 00812444020458

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Brachytherapy needle
Primary Device ID00812444020458
NIH Device Record Key40b88001-ec16-47b2-b5c6-1d20a3b1ee7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRIVERPONT BRACHYTHERAPY
Version Model Number1200-1820-1
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812444020458 [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 Date2015-10-21

Devices Manufactured by RIVERPOINT MEDICAL, LLC

00840277405579 - RootMend™ MRR (Black)2025-05-09 Adjustable Loop
00840277405586 - RootMend™ MRR (Blue)2025-05-09 Adjustable Loop
00840277405593 - RootMend™ MRR 2025-05-09 Titanium Button
00840277405647 - RootMend™ MRR Soft Button (Black)2025-05-09 Adjustable Loop
00840277405654 - RootMend™ MRR Soft Button (Blue)2025-05-09 Adjustable Loop
00840277402196 - PERMACORD™ Stiffened Suture2025-05-06 Size 2 Stiffened Suture Blue, UHMWPE Non-absorbable Suture
00840277402219 - PERMACORD™ Stiffened Suture2025-05-06 Size 2 Stiffened Suture White/Blue, UHMWPE Non-absorbable Suture
00840277402233 - PERMALOOP™ MINI Stiffened Suture2025-05-06 1.4mm Stiffened Suture Tape w/ Looped End Blue, UHMWPE Non-absorbable Suture

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