FDA.reportPublic FDA data

NA

Primary DI
00724995150327
Brand
NA
Company
Steris Mexico, S. de R.L. de C.V.
Model
AX081020003
Catalog number
AX081020003
Device description
The Atlas Transfer Carriage, Painted Carbon Steel 26-inch x 37.5-inch x 42-inch is designed for use with 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
K112055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112055000AMSCO CHIMERON MEDIUM STEAM STERILIZERSTERIS Corporation2011-12-16FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995150327PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995150327007249951503277249951503270724995150327

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
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
00724995150570AmscoAX067111AX0671112016-09-14

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