FDA.reportPublic FDA data

AMSCO V-PRO

Primary DI
00724995151997
Brand
AMSCO V-PRO
Company
Steris Mexico, S. de R.L. de C.V.
Model
maX
Catalog number
VP3
Device description
The Amsco V-PRO maX Low Temperature Sterilization System is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices used in Healthcare Facilities.
Published
2016-09-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLRSterilizer, chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102330000AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEMSTERIS Corporation2011-08-12MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995151997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995151997007249951519977249951519970724995151997

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide gas sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using hydrogen peroxide (H2O2) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It includes a treatment chamber where the devices to be sterilized are placed, usually after cleaning of gross debris, and a means to introduce the gas into the chamber; it is not intended to generate a gas plasma. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
813116209
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995179168AMSCOAMSCO 600 Steam SterilizerEF11024322021-04-02
00724995179298AMSCOAMSCO 600 Steam SterilizerEF12023102021-04-02
00724995197414AMSCOAMSCO 600 Steam SterilizerEF1202442001022021-04-02
00724995223274AMSCOAMSCO 600 Steam SterilizerEF110232023-02-13
07350109400281NA15990-2215990222022-10-26
07350109400298NA15990-2315990232022-10-26
07350109400304NA15990-2415990242022-10-26
00724995196455AMSCOAMSCO 600 Steam SterilizerEF1102410001012021-09-27
00724995196462AMSCOAMSCO 600 Steam SterilizerEF1102310001012021-09-27
00724995196493AMSCOAMSCO 600 Steam SterilizerEF1102422001012021-09-27
00724995196509AMSCOAMSCO 600 Steam SterilizerEF1102322001012021-09-27
00724995196530AMSCOAMSCO 600 Steam SterilizerEF1102432001012021-09-27
00724995196547AMSCOAMSCO 600 Steam SterilizerEF1102332001012021-09-27
00724995196578AMSCOAMSCO 600 Steam SterilizerEF1102440001012021-09-27
00724995196585AMSCOAMSCO 600 Steam SterilizerEF1102340001012021-09-27
00724995196615AMSCOAMSCO 600 Steam SterilizerEF1102442001012021-09-27
00724995196622AMSCOAMSCO 600 Steam SterilizerEF1102342001012021-09-27
00724995196639AMSCOAMSCO 600 Steam SterilizerEF1201210001012021-09-27
00724995196646AMSCOAMSCO 600 Steam SterilizerEF1201110001012021-09-27
00724995196653AMSCOAMSCO 600 Steam SterilizerEF1202410001012021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800066500306STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
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00889024636132Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636170Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636187Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636224Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636231Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636255Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636279Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636286Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636309Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636323Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636330Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636378Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636385Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636408Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636415Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636439Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636453Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636460Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636477Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636507Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636545Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636583Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636613Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636675Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636682Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636699Trilogy®Zimmer, Inc.MLR2022-02-25
00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29