AOS Marker Seeds

GUDID 00850645007007

ALPHA-OMEGA SERVICES, INC.

Radiological image marker, implantable

• Primary Device ID: 00850645007007
• NIH Device Record Key: ed5f5a7d-d504-4d25-95ee-2d243e499bd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AOS Marker Seeds
• Version Model Number: SMG0242-025
• Company DUNS: 060398989
• Company Name: ALPHA-OMEGA SERVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00850645007007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233626

FDA Product Code

• KXK: Source, Brachytherapy, Radionuclide

Sterilization

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

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

[00850645007007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-23
• Device Publish Date: 2024-07-15

Devices Manufactured by ALPHA-OMEGA SERVICES, INC.

• 00850645007113 - AOS Interstitial Templates, Needles, and Accessories: 2024-07-26 COLLAR AND LARGE O-RING WHITE, FOR SERIES-15 & 17 GYN-3 TEMPLATE, DISPOSABLE
• 00850645007304 - AOS Interstitial Templates, Needles, and Accessories: 2024-07-26 Guide, Vaginal, Series-17, 12 cm, with Blue set screw, 1 ea
• 00850645007373 - AOS Interstitial Templates, Needles, and Accesories: 2024-07-26 Guide, Vaginal, Series-15, 12 cm, with Yellow set screw, 1 ea
• 00850645007380 - AOS Interstitial Templates, Needles, and Accesories: 2024-07-26 Guide, Vaginal, Series-15, 15 cm, with Yellow set screw, 1 ea
• 00850645007571 - AOS Interstitial Templates, Needles, and Accesories: 2024-07-26 Guide, Vaginal, Series-17, 15 cm, with Blue set screw, 1 ea
• 00850645007588 - AOS Interstitial Templates, Needles, and Accesories: 2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 10 ea
• 00850645007595 - AOS Interstitial Templates, Needles, and Accesories: 2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 15 ea
• 00850645007601 - AOS Interstitial Templates, Needles, and Accesories: 2024-07-26 Needle, Template Stainless Steel with Threaded Female Hub and Stylet with 90 degree bend, Series-17, 20 cm, 20 ea