AOS GYN-3 Template, Syed/Neblett/Hedger

GUDID 00850645007458

Template, Syed/Neblett/Hedger, Series-17, GYN-3 (54 Holes), Blue, 1 ea

ALPHA-OMEGA SERVICES, INC.

Vaginal brachytherapy system applicator, remote-afterloading
Primary Device ID00850645007458
NIH Device Record Keydcae51e3-6c55-46d1-a771-2abf8794dde8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS GYN-3 Template, Syed/Neblett/Hedger
Version Model NumberTGD0003-017
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
GS100850645007458 [Primary]

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

Ethylene Oxide


[00850645007458]

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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00850645007304 - AOS Interstitial Templates, Needles, and Accessories2024-07-26 Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea
00850645007373 - AOS Interstitial Templates, Needles, and Accesories2024-07-26 Guide, Vaginal, Series-15, 12 cm, with Yellow set screw, 1 ea
00850645007380 - AOS Interstitial Templates, Needles, and Accesories2024-07-26 Guide, Vaginal, Series-15, 15 cm, with Yellow set screw, 1 ea
00850645007571 - AOS Interstitial Templates, Needles, and Accesories2024-07-26 Guide, Vaginal, Series-17, 15 cm, with Blue set screw, 1 ea
00850645007588 - AOS Interstitial Templates, Needles, and Accesories2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 10 ea
00850645007595 - AOS Interstitial Templates, Needles, and Accesories2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 15 ea
00850645007601 - AOS Interstitial Templates, Needles, and Accesories2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 20 ea

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