AOS Implant Needle, Series-17, 15 cm, 30°

GUDID 00850645007069

Needle, Implant, Series-17, 15 cm, 30°, 10 ea

ALPHA-OMEGA SERVICES, INC.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00850645007069
NIH Device Record Key2720b278-1e98-49af-ab59-c9c3cf190146
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS Implant Needle, Series-17, 15 cm, 30°
Version Model NumberNID0001-008
Company DUNS060398989
Company NameALPHA-OMEGA SERVICES, INC.
Device Count10
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
GS100850645007069 [Primary]
GS100850645007656 [Unit of Use]

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850645007069]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-10-05

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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