AOS Implant Tube, Tongue/Soft Tissue, Puthawala/Syed

GUDID 00850645007212

Implant Tube, Tongue/Soft Tissue, Puthawala/Syed, 28 cm Leader, 85 cm Body, 15 cm Draw-Down, Cable Insert, with Green Nylon Retaining Buttons, 10 ea

ALPHA-OMEGA SERVICES, INC.

Tongue brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00850645007212
• NIH Device Record Key: f9889569-d6f3-4ab0-945b-ef1b3c57b7d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS Implant Tube, Tongue/Soft Tissue, Puthawala/Syed
• Version Model Number: TIT0001-004
• Company DUNS: 060398989
• Company Name: ALPHA-OMEGA SERVICES, INC.
• Device Count: 10
• 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	00850645007212 [Primary]
GS1	00850645007748 [Unit of Use]

FDA Product Code

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

Sterilization

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

[00850645007212]

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: 2016-10-05

On-Brand Devices [AOS Implant Tube, Tongue/Soft Tissue, Puthawala/Syed]

• 00850645007229: Implant Tube, Tongue/Soft Tissue, Puthawala/Syed, 28 cm Leader, 85 cm Body, 15 cm Draw-Down, Cab
• 00850645007212: Implant Tube, Tongue/Soft Tissue, Puthawala/Syed, 28 cm Leader, 85 cm Body, 15 cm Draw-Down, Cab