AOS Implant Tube, Intralumenal

GUDID 00850645007168

Implant Tube, Intralumenal, 100 cm, without Gold Seed, 1 ea

ALPHA-OMEGA SERVICES, INC.

General-purpose brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00850645007168
• NIH Device Record Key: b75bef0d-30ec-447b-9281-def49bd0628c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS Implant Tube, Intralumenal
• Version Model Number: TII0004-001
• 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	00850645007168 [Primary]

FDA Product Code

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

Sterilization

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

[00850645007168]

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 Implant Tube, Intralumenal]

• 00850645007199: Implant Tube, Intralumenal, 200 cm, with 5 mm Gold Seed, 1 ea
• 00850645007182: Implant Tube, Intralumenal, 150 cm, with 5 mm Gold Seed, 1 ea
• 00850645007175: Implant Tube, Intralumenal, 100 cm, with 5 mm Gold Seed, 1 ea
• 00850645007168: Implant Tube, Intralumenal, 100 cm, without Gold Seed, 1 ea
• 00850645007151: Implant Tube, Intralumenal, 130 cm Body, 10 cm Draw-Down, Sealed End, Cable Insert, and Gold See
• 00850645007144: Implant Tube, Intralumenal, 130 cm Body, 10 cm Draw-Down, Sealed End, Cable Insert, and Gold See