AOS Implant Needle, Series-17, 20 cm, 30°

GUDID 00850645007090

Needle, Implant, Series-17, 20 cm, 30°, 10 ea

ALPHA-OMEGA SERVICES, INC.

General-purpose brachytherapy system applicator, remote-afterloading
Primary Device ID00850645007090
NIH Device Record Keyff2d78f0-626e-47a3-ac72-a70c02b22c93
Commercial Distribution StatusIn Commercial Distribution
Brand NameAOS Implant Needle, Series-17, 20 cm, 30°
Version Model NumberNID0001-011
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
GS100850645007090 [Primary]
GS100850645007687 [Unit of Use]

FDA Product Code

JAQSystem, Applicator, Radionuclide, Remote-Controlled

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850645007090]

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.

00850645007014 - AOS Retaining Button (Syed Type), Green Nylon2019-02-07 Button, Retaining (Syed Type), Green Nylon, 10 ea
00850645007021 - AOS Retaining Button, Stainless Steel2019-02-07 Button, Retaining, Stainless Steel, 10 ea
00850645007038 - AOS Retaining Button (Syed Type), White Nylon2019-02-07 Button, Retaining (Syed Type), White Nylon, 10 ea
00850645007045 - AOS Retaining Button (Syed Type), Radiopaque2019-02-07 Button, Retaining (Syed Type), Radiopaque, 10 ea
00850645007052 - AOS Implant Needle, Series-17, 15 cm, 14°2019-02-07 Needle, Implant, Series-17, 15 cm, 14°, 10 ea
00850645007069 - AOS Implant Needle, Series-17, 15 cm, 30°2019-02-07 Needle, Implant, Series-17, 15 cm, 30°, 10 ea
00850645007076 - AOS Implant Needle, Series-17, 15 cm, 45°2019-02-07 Needle, Implant, Series-17, 15 cm, 45°, 10 ea
00850645007083 - AOS implant Needle, Series-17, 20 cm, 14°2019-02-07 Needle, Implant, Series-17, 20 cm, 14°, 10 ea

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