FDA.reportPublic FDA data

AMSCO

Primary DI
00724995196486
Brand
AMSCO
Company
Steris Mexico, S. de R.L. de C.V.
Model
AMSCO 600 Steam Sterilizer
Catalog number
EF110112200101
Device description
The AMSCO 600 STERI-Green Plus is designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Published
2021-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FLESterilizer, steam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLESterilizer, SteamGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183410000AMSCO 600 Steam SterilizerSTERIS Corporation2019-03-27FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995196486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995196486007249951964867249951964860724995196486

GMDN Terms#

Term, Definition table
TermDefinition
Steam sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. 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

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