FDA.reportPublic FDA data

NA

Primary DI
00724995150433
Brand
NA
Company
Steris Mexico, S. de R.L. de C.V.
Model
AX084010001
Catalog number
AX084010001
Device description
The Atlas Loading Car 26-inch x 26-inch x 39-inch is designed for use with the sterilization systems.
Published
2016-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
K082435000
K203061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082435000AMSCO EVOLUTION MEDIUM STEAM STERILIZERSTERIS Corporation2008-12-30FLE
K203061000Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-600 and HC-1500),Evolution Automated Loading and Unloading System (ALUS); Amsco EvolutionMedium Steam Sterilizer (Models HC-800 and HC-1000),Evolution Automated Loading and Unloading System (ALUS)STERIS Corporation2020-11-06FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995150433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995150433007249951504337249951504330724995150433

GMDN Terms#

Term, Definition table
TermDefinition
Sterilizer/disinfector rackA non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Width0

Contacts#

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

Regulatory Flags#

DUNS number
813116209
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00724995150440NAAX085020003AX0850200032016-09-14
00724995150457NAAX085020001AX0850200012016-09-14
00724995150464NAAX085010001AX0850100012016-09-14
00724995150471NAAX086020003AX0860200032016-09-14
00724995150488NAAX086010001AX0860100012016-09-14
00724995150549AtlasAX067013081AX0670130812016-09-14
00724995150556AtlasAX0640230830000013AX06402308300000132016-09-14
00724995150563AtlasAX061023083AX0610230832016-09-14
00724995150570AmscoAX067111AX0671112016-09-14

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