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 ID: 00850645007458
• NIH Device Record Key: dcae51e3-6c55-46d1-a771-2abf8794dde8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS GYN-3 Template, Syed/Neblett/Hedger
• Version Model Number: TGD0003-017
• Company DUNS: 060398989
• Company Name: ALPHA-OMEGA SERVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850645007458 [Primary]

FDA Product Code

• JAQ: System, Applicator, Radionuclide, Remote-Controlled

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00850645007458]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-04

Devices Manufactured by ALPHA-OMEGA SERVICES, INC.

• 00850645007014 - AOS Retaining Button (Syed Type), Green Nylon: 2019-02-07 Button, Retaining (Syed Type), Green Nylon, 10 ea
• 00850645007021 - AOS Retaining Button, Stainless Steel: 2019-02-07 Button, Retaining, Stainless Steel, 10 ea
• 00850645007038 - AOS Retaining Button (Syed Type), White Nylon: 2019-02-07 Button, Retaining (Syed Type), White Nylon, 10 ea
• 00850645007045 - AOS Retaining Button (Syed Type), Radiopaque: 2019-02-07 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