STERIS MEXICO, S. de R.L. de C.V.

AMSCO 400 Series Medium Steam Sterilizer Models 39SL, 39CSL (MY-MF) V-PRO 60 Low Temperature Sterilization System (MY-CFE) VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD) V-PRO S2 Low Temperature Sterilization System (MY-MF, CM-SD) Loading Car 26x26x61-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x49-inch (MY-MF) Loading Car 26x26x49-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x61-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x49-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x61-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-800, HC-1000 (MY-MF) VAPROX HC Sterilant (PB007) (MM-MF, CM-SD) AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE) AMSCO C Series Steam Sterilizer Models 16C, 16CS, 20C, 20CS (MY-REM) AMSCO Series 400 Steam Sterilizer Models 16, 16S, 20, 20S (MY-MF) AMSCO 400 Medium Steam Sterilizer 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL, 60CSL (MY-MF) AMSCO Evolution Floorloading Steam Sterilizer Models HC-3000 (MY-MF) AMSCO Evolution Floorloading Steam Sterilizer Models HC-2000 (MY-MF) AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE) AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE) AMSCO 600 Steam Sterilizer (MY-MF) Extra Shelf for Loading Car (MY-CFE) AMSCO 600 Extra Shelf for Rack and 2 Shelves (AX000B7) (MY-MF) AMSCO 600 Rack and 2 Shelves (AX000B6) (MY-MF) Loading Car with 2 Shelves (MY-CFE) ALUS Load/Unload Table for AMSCO 600 Steam Sterilizer (MY-CFE) Loading Car Side and End Rails (MY-CFE) AMSCO Century Small Steam Sterilizer Models V-116, V-120 Amsco V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) AMSCO Evolution Medium Steam Sterilizer Models HC-900 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-1200 (MY-MF) Amsco V-PRO 1 Low Temperature Sterilization Systems (MY-CFE) Eagle Rack & Three Shelves 16x16x26-inch (MY-MF) ATLAS Loading Car 24x36x60-inch (MY-MF) Eagle Bottom Shelf & Support 16x16x26-inch (MY-MF) Eagle Rack & Three Shelves 20x20x38-inch (MY-MF) Eagle Shelf for 37 3/8-inch Chambers (MY-MF) Eagle Rack & Two Shelves 20x20x38-inch (MY-MF) ATLAS Loading Car and Transfer Carriage 24x36x48-inch (MY-MF) Rack & Two Shelves 24x36x48-inch for Single Door (MY-MF) Rack & Two Shelves 24x36x36-inch (MY-MF) ATLAS Transfer Carriage 24x36x48-inch (MY-MF) ATLAS Loading Car 24x36x48-inch (MY-MF) Eagle Loading Cart 24 1/4x57 5/8x37 3/8-inch (MY-MF) Eagle Rack & Two Shelves 16x16x26-inch (MY-MF) Amsco Eagle 3000 Series Remanufactured Steam Sterilizer (MY-CFE) Eagle Loading Cart 24 1/4x38x37 3/8-inch (MY-MF) ATLAS Loading Car 24x36x36-inch (MY-MF) ATLAS Transfer Carriage 24x36x36-inch (MY-MF) Eagle Bottom Shelf & Support 20x20x38-inch (MY-MF) Rack & Two Shelves 24x36x48-inch for Double Door (MY-MF) ATLAS Transfer Carriage 24x36x60-inch (MY-MF) AMSCO 600 STEAM Sterilizer (MY-MF) V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD) AMSCO Eagle 3017 EO sterilizer (MY-CFE) AMSCO Evolution Medium Steam Sterilizer Models HC-1500 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-600 (MY-MF) AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE) V-PRO maX 2 Low Temperature Sterilization System (MY-MF) RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector (QB-MF) V-PRO s2 Low Temperature Sterilization System (MY-MF) RAS 12 Long Rack (FD257) (QB-MF) RAS 12 Rack (FD256) (QB-MF) ATLAS Transfer Carriage 26x37.5x36" Hinged Door (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-900, HC-1200 (MY-MF) ATLAS Loading Car 26x37.5x48" (MY-MF) ATLAS Loading Car 26x37.5x36" (MY-MF) Shelf, Full Width/Length 26x37.5x36" (MY-MF) ATLAS Transfer Carriage 26x37.5x48" Hinged Door (MY-MF) Rack & Two 36" Shelves 26x37.5x36 for Evolution Amsco 400 Century (MY-MF) ATLAS Transfer Carriage 26x37.5x48" Horizontal Sliding Door (MY-MF) ATLAS Transfer Carriage 26x37.5x36" for Horizontal Sliding Door (MY-MF) VAPROX HC Sterilant (PB011 and PB012) (MM-MF, CM-SD) Amsco Eagle 3000 Series Vacamatic Floorloader (MY-CFE) AMSCO Evolution Medium Steam Sterilizer Models HC-1000 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Models HC-800 (MY-MF) ATLAS Transfer Carriage 26x37.5x36-inch for Horizontal Sliding Door (MY-MF) Shelf, Full Width/Length 26x37.5x36-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x49-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-1500 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-1000 (MY-MF) ATLAS Loading Car 26x37.5x48-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x61-inch (MY-MF) ATLAS Loading Car 26x37.5x36-inch (MY-MF) ATLAS Transfer Carriage 26x37.5x48-inch Horizontal Sliding Door (MY-MF) Loading Car 26x26x39-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-900 (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-600 (MY-MF) Transfer Carriage, Painted Carbon Steel 26x26x39-inch (MY-MF) Transfer Carriage, Stainless Steel 26x26x39-inch (MY-MF) ATLAS Loading Car 26x37.5x60-inch (MY-MF) ATLAS Transfer Carriage 26x37.5x48-inch Hinged Door (MY-MF) Evolution ALUS Load/Unload Table (MY-CFE) ATLAS Transfer Carriage 26x37.5x60-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-1200 (MY-MF) Loading Car 26x26x61-inch (MY-MF) AMSCO Evolution Medium Steam Sterilizer Model HC-800 (MY-MF) ATLAS Transfer Carriage 26x37.5x36-inch Hinged Door (MY-MF) Amsco V-PRO 1 Low Temperature Sterilization System (MY-CFE) V-PRO maX Low Temperature Sterilization System (MY-CFE, CM-SD) Amsco 400 Small Loading Rack & Two Shelves for Single Door (MY-MF) Amsco 400 Small Loading Rack & Two Shelves for Double Door (MY-MF) ATLAS Loading Car 20x20x38-inch (MY-MF) ATLAS Transfer Carriage 20x20x38-inch (MY-MF) AMSCO 400 Series 20-inch Intermediate Shelf (MY-MF) EVOLUTION ALUS LOAD TABLE (MY-CFE) AMSCO Evolution Medium Steam Sterilizer Models HC-600, HC-1500 (MY-MF) EVOLUTION ALUS UNLOAD TABLE (MY-CFE) ATLAS Transfer Carriage 26x37.5x60-inch Hinged (MY-MF) ATLAS Transfer Carriage 26x37.5x60-inch Horizontal (MY-MF) V-PRO S2 Low Temperature Sterilization System (MY-MF) Transfer Carriage, Stainless Steel 26x37.5x42-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x37.5x66-inch (MY-MF) Transfer Carriage, Painted Carbon Steel 26x37.5x54-inch (MY-MF) AMSCO 400 Medium Steam Sterilizer 36H, 48H, 60H, 36SL, 48SL, 60SL, 36CH, 48CH, 60CH, 36CSL, 48CSL, 60CSL (MY-MF) Transfer Carriage, Painted Carbon Steel 26x37.5x42-inch (MY-MF) Transfer Carriage, Stainless Steel 26x37.5x66-inch (MY-MF) Loading Car 26x37.5x42-inch (MY-MF) Loading Car 26x37.5x54-inch (MY-MF) Transfer Carriage, Stainless Steel 26x37.5x54-inch (MY-MF) Loading Car 26x37.5x66-inch (MY-MF)

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device