Sterrad 10104-003

GUDID 10705037047581

Sterrad 100 NX 1-DR with DUO

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer Plasma sterilizer 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