ULTRA GI™ 43381

GUDID 10705037070718

ULTRA GI™ Cycle Validation Kit

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Biological sterilization indicator

• Primary Device ID: 10705037070718
• NIH Device Record Key: 5502c7d1-5853-49a8-8f5a-64777cbd61c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA GI™
• Version Model Number: 43381
• Catalog Number: 43381
• Company DUNS: 947451626
• Company Name: ADVANCED STERILIZATION PRODUCTS SERVICES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• 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: true

Customer Support Contacts

• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com
• Phone: +1(888)783-7723
• Email: asp-contactus@asp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037070718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234082

FDA Product Code

• FRC: Indicator, biological sterilization process

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

Devices Manufactured by ADVANCED STERILIZATION PRODUCTS SERVICES INC.

• 10705037070718 - ULTRA GI™: 2025-12-23ULTRA GI™ Cycle Validation Kit
• 10705037070718 - ULTRA GI™: 2025-12-23 ULTRA GI™ Cycle Validation Kit
• 20705037014658 - Sterrad: 2025-05-26 Sterrad 200 Cassette
• 10705037067190 - Aptimax Instrument TRAY for ULTRA GI Cycle: 2024-10-03 Instrument Tray, Reusable
• 10705037068425 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle: 2024-10-03 Plasma Sterilizer
• 10705037068432 - STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle: 2024-10-03 Plasma Sterilizer
• 10705037069583 - ULTRA GI Cycle Validation Kit: 2024-10-03 STERRAD 100NX System ULTRA GI Cycle Validation Kit
• 20705037069368 - ULTRA GI Process Challenge Device (PCD) Vial: 2024-10-03 ULTRA GI Cycle Process Challenge Device Vial
• 10705037069316 - Evotech: 2024-06-28 Channel Connector Tube, Orange