AOS Flexiguide Needle

GUDID 00850645007328

Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm, 15 ea

ALPHA-OMEGA SERVICES, INC.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00850645007328
• NIH Device Record Key: 4d156827-e712-4228-8125-3511b2a1524f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS Flexiguide Needle
• Version Model Number: NFV0002-003
• Company DUNS: 060398989
• Company Name: ALPHA-OMEGA SERVICES, INC.
• Device Count: 15
• 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	00850645007328 [Primary]
GS1	00850645007793 [Unit of Use]

FDA Product Code

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

Sterilization

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

[00850645007328]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-10-05

On-Brand Devices [AOS Flexiguide Needle]

• 00850645007366: Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 25 cm,
• 00850645007359: Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 20 cm,
• 00850645007342: Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 20 cm,
• 00850645007335: Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm,
• 00850645007328: Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm,
• 00850645007311: Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 20 cm,
• 00850645007298: Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-15, 25 cm,
• 00850645007281: Needle, Flexiguide with Female Luer Adaptor and Stylet with Male Luer Adaptor, Series-17, 25 cm,