AOS Interstitial Templates, Needles, and Accessories

GUDID 00850645007304

Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea

ALPHA-OMEGA SERVICES, INC.

Vaginal brachytherapy system applicator, remote-afterloading

• Primary Device ID: 00850645007304
• NIH Device Record Key: 5095933e-5f32-4918-bd97-18edd8c17418
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS Interstitial Templates, Needles, and Accessories
• Version Model Number: GVN1517-005
• Company DUNS: 060398989
• Company Name: ALPHA-OMEGA SERVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850645007304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233628

FDA Product Code

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

Sterilization

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

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

[00850645007304]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [AOS Interstitial Templates, Needles, and Accessories]

• 00850645007304: Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea
• 00850645007113: COLLAR AND LARGE O-RING WHITE, FOR SERIES-15 & 17 GYN-3 TEMPLATE, DISPOSABLE