AOS Rectal Template, Syed/Neblett/Hedger

GUDID 00850645007489

Template, Syed/Neblett/Hedger, Series-15, Rectal, (36 Holes), Yellow, 1 ea

ALPHA-OMEGA SERVICES, INC.

Anorectal brachytherapy system applicator, remote-afterloading
Primary Device ID00850645007489
NIH Device Record Key10f6b81d-03ae-4753-9c3f-32e679220a1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS Rectal Template, Syed/Neblett/Hedger
Version Model NumberTRD0001-015
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
GS100850645007489 [Primary]

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


[00850645007489]

Ethylene Oxide


Device Entry Metadata

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

Devices Manufactured by ALPHA-OMEGA SERVICES, INC.

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