FDA.reportPublic FDA data

AMSCO

Primary DI
00724995196745
Brand
AMSCO
Company
Steris Mexico, S. de R.L. de C.V.
Model
AMSCO 600 Steam Sterilizer
Catalog number
EF120233200101
Device description
The AMSCO 600 STERI-Green+ is designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Published
2021-09-27
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
00724995196745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995196745007249951967457249951967450724995196745

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
00724995150327NAAX081020003AX0810200032016-09-14
00724995150334NAAX081020001AX0810200012016-09-14
00724995150341NAAX081010001AX0810100012016-09-14
00724995150358NAAX082020003AX0820200032016-09-14
00724995150365NAAX082020001AX0820200012016-09-14
00724995150372NAAX082010001AX0820100012016-09-14
00724995150389NAAX083020003AX0830200032016-09-14
00724995150396NAAX083020001AX0830200012016-09-14
00724995150402NAAX083010001AX0830100012016-09-14
00724995150419NAAX084020003AX0840200032016-09-14
00724995150426NAAX084020001AX0840200012016-09-14
00724995150433NAAX084010001AX0840100012016-09-14
00724995150440NAAX085020003AX0850200032016-09-14
00724995150457NAAX085020001AX0850200012016-09-14
00724995150464NAAX085010001AX0850100012016-09-14
00724995150471NAAX086020003AX0860200032016-09-14
00724995150488NAAX086010001AX0860100012016-09-14
00724995150549AtlasAX067013081AX0670130812016-09-14
00724995150556AtlasAX0640230830000013AX06402308300000132016-09-14
00724995150563AtlasAX061023083AX0610230832016-09-14

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06972615108003icanclaveNingbo Ican Machines Co., Ltd.FLE2025-12-19
05904165664280EnbioENBIO TECHNOLOGY SP Z O OFLE2025-10-28
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06971608311505ADSGuangzhou Ajax Medical Equipment Co., Ltd.FLE2025-09-15
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