AOS Vaginal Guide

GUDID 00850645007274

Guide, Vaginal, Series-15, 15 cm, Yellow Set Screw, 1 ea

ALPHA-OMEGA SERVICES, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00850645007274
NIH Device Record Keyfca3a782-0ece-402b-9140-af8156d01c85
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS Vaginal Guide
Version Model NumberGVN1517-008
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
GS100850645007274 [Primary]

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850645007274]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-05

On-Brand Devices [AOS Vaginal Guide]

00850645007274Guide, Vaginal, Series-15, 15 cm, Yellow Set Screw, 1 ea
00850645007267Guide, Vaginal, Series-17, 15 cm, Blue Set Screw, 1 ea
00850645007250Guide, Vaginal, Series-15, 12 cm, Yellow Set Screw, 1 ea
00850645007243Guide, Vaginal, Series-17, 12 cm, Blue Set Screw, 1 ea

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.