STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle

GUDID 10705037068432

Plasma Sterilizer

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Plasma sterilizer

• Primary Device ID: 10705037068432
• NIH Device Record Key: 737ab1fa-7226-4099-b879-c21e96c4e327
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle
• Version Model Number: 10104-010
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com
• Phone: +1(888)783-7723
• Email: ASP-Complaints@asp.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -29 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037068432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K234082

FDA Product Code

• MLR: Sterilizer, chemical

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: 2024-10-03
• Device Publish Date: 2024-09-25

On-Brand Devices [STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle]

• 10705037068432: Plasma Sterilizer
• 10705037068425: Plasma Sterilizer