RP Spacer

GUDID 00812444027921

BRACHYTHERAPY

RIVERPOINT MEDICAL, LLC

Brachytherapy source spacer
Primary Device ID00812444027921
NIH Device Record Key674e4f3b-0d61-4a60-9374-1f60dd99e053
Commercial Distribution StatusIn Commercial Distribution
Brand NameRP Spacer
Version Model NumberRPS-910-5.5-50
Company DUNS964053560
Company NameRIVERPOINT MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS100812444027921 [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 Date2018-02-15

On-Brand Devices [RP Spacer]

00812444027921BRACHYTHERAPY
00812444026696SEEDING SPACER

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