AOS Prostate Template, Syed/Neblett/Hedger

GUDID 00850645007465

Template, Syed/Neblett/Hedger, Series-15, Prostate, (18 Holes), Yellow, 1 ea

ALPHA-OMEGA SERVICES, INC.

Prostate brachytherapy system applicator, remote-afterloading
Primary Device ID00850645007465
NIH Device Record Key4145e897-cd8b-4cc3-957f-993bd9a20ab0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS Prostate Template, Syed/Neblett/Hedger
Version Model NumberTPD0001-015
Company DUNS060398989
Company NameALPHA-OMEGA SERVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850645007465 [Primary]

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850645007465]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-04

On-Brand Devices [AOS Prostate Template, Syed/Neblett/Hedger]

00850645007472Template, Syed/Neblett/Hedger, Series-17, Prostate, (18 Holes), Blue, 1 ea
00850645007465Template, Syed/Neblett/Hedger, Series-15, Prostate, (18 Holes), Yellow, 1 ea

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