FDA.reportPublic FDA data

NA

Primary DI
07350109400113
Brand
NA
Company
Steris Mexico, S. de R.L. de C.V.
Model
15966-44
Catalog number
1596644
Device description
The Extra Shelf for Loading Car (8STU, 51-Inch, 1290 mm) is used with the AMSCO 600 Steam Sterilizer.
Published
2019-08-17
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
K211500000
K232485000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183410000AMSCO 600 Steam SterilizerSTERIS Corporation2019-03-27FLE
K211500000AMSCO 600 Medium Steam SterilizerSTERIS Corporation2021-08-25FLE
K232485000AMSCO 600 Steam SterilizerSteris2023-09-13FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350109400113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350109400113073501094001137350109400113

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
Width51Inch
Width63Inch

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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