Sterrad 10104-003

GUDID 10705037047581

Sterrad 100 NX 1-DR with DUO

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Plasma sterilizer

• Primary Device ID: 10705037047581
• NIH Device Record Key: 92154d33-ec02-40fa-9187-ccc03e3c55d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterrad
• Version Model Number: 10104-003
• Catalog Number: 10104-003
• 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: true
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705037047581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071385

FDA Product Code

• MLR: Sterilizer, chemical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-06-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Sterrad]

• 10705037047550: Sterrad 100NX Test Pack
• 10705037016594: Sterrad NX Validation Kit
• 10705037016587: Sterrad NX Validation Kit
• 10705037016570: Sterrad Starter Kit (50/100S/NX)
• 10705037016556: Sterrad NX Test Pack
• 10705037016532: Sterrad 50/100S Sterilizer Cyclesure 24 Validation Kit
• 10705037016525: Sterrad 200 Sterilizer CycleSure 24 Validation Kit
• 10705037016518: 50/100S Sterilizer Cyclesure 24 Validation Kit
• 10705037016501: Sterrad 100NX Validation Kit
• 10705037016495: Sterrad 100NX International Validation Kit
• 10705037016396: Sterrad 100NX Express Test Pack
• 10705037016235: Sterrad CycleSure 24 Test Pack
• 20705037064479: Instrument Tray Mats 254 mm X 254 mm (10 in. x 10 in.)
• 10705037047635: Instrument Tray Holder Kit
• 10705037047628: Sterrad Mat Kit
• 20705037043177: Holder Bar for Instrument Tray
• 20705037043160: Holder 5 mm x 5 mm x 5 mm
• 20705037043153: Holder 15 mm x 15 mm x 15 mm
• 20705037043146: Holder 10 mm x 10 mm x 10 mm
• 20705037043139: Holder 19 mm x 5 mm x 19 mm
• 20705037043122: Holder 5 mm x 19 mm x 5 mm
• 20705037043115: Holder 19 mm x 10 mm 19 mm
• 20705037043108: Holder 10 mm x 19 x 10 mm
• 20705037043061: Instrument Tray Mats 584 mm X 191 mm (23 in. x 7.5 in.)
• 20705037043054: Instrument Tray Mats 432 mm X 191 mm (17 in. x 7.5 in.)
• 20705037043047: Instrument Tray Mats 279 mm X 191 mm(11 in. x 7.5 in.)
• 20705037043030: Instrument Tray Mats 356 mm X 241 mm (14 in. x 9.5 in.)
• 20705037043023: Instrument Tray Mats 356 mm X 140 mm (14 in. x 5.5 in.)
• 20705037043016: Instrument Tray Mats 229 mm X 140 mm (9 in. x 5.5 in.)
• 20705037043009: Instrument Tray Mats165 mm X 64 mm (6.5 in. x 2.5 in.)
• 20705037049407: STERRAD VELOCITY BIOLOGICAL INDICATOR
• 10705037048915: STERRAD VELOCITY READER
• 20705037048905: STERRAD VELOCITY BIOLOGICAL INDICATOR
• 10705037048700: STERRAD 100NX, Systems with ALLClear Technology, 2 Doors, DUO
• 10705037048694: STERRAD 100NX, Systems with ALLClear Technology, DUO
• 10705037048687: STERRAD 100NX, Systems with ALLClear Technology, 2 Doors
• 10705037048670: STERRAD 100NX Sterilization System with ALLClear Technology
• 10705037048656: STERRAD NX Sterilization System with ALLClear Technology
• 10705037041657: Thermometer
• 10705037016952: Incubator 120V 58 C
• 20705037016195: Chemical Indicator Strip
• 10705037015191: Carriage Sterrad 200 4 Wheels
• 10705037015184: Shelf Sterrad 200 2-Tier
• 20705037014900: Sterrad 100 NX Cassette
• 20705037014832: Sterrad NX Cassette
• 20705037014580: Sterrad 100s Cassette
• 10705037047598: Sterrad 100 NX 2-DR, with DUO
• 10705037047581: Sterrad 100 NX 1-DR with DUO
• 10705037014507: Sterrad 100 NX 2-DR
• 10705037014491: Sterrad 100 NX Sterilizer