FDA.reportPublic FDA data

NA

Primary DI
07350109400304
Brand
NA
Company
Steris Mexico, S. de R.L. de C.V.
Model
15990-24
Catalog number
1599024
Device description
The ALUS Table, Domestic (10STU, 63IN, 1590MM) is used with the AMSCO 600 Steam Sterilizer.
Published
2022-10-26
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
PECSterilizer automated loading system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PECSterilizer Automated Loading SystemGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211500000AMSCO 600 Medium Steam SterilizerSTERIS Corporation2021-08-25FLE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350109400304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350109400304073501094003047350109400304

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
Width27Inch

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
00724995364168AMSCOAMSCO 700 Steam SterilizerEJ11202210012026-10-08
00724995364175AMSCOAMSCO 700 Steam SterilizerEJ11201400012026-10-08
00724995364182AMSCOAMSCO 700 Steam SterilizerEJ11202410012026-10-08
00724995364199AMSCOAMSCO 700 Steam SterilizerEJ11201410012026-10-08
00724995364205AMSCOAMSCO 700 Steam SterilizerEJ12201100012026-10-08
00724995364212AMSCOAMSCO 700 Steam SterilizerEJ12201400012026-10-08
00724995364229AMSCOAMSCO 700 Steam SterilizerEJ12202410012026-10-08
00724995364236AMSCOAMSCO 700 Steam SterilizerEJ12201410012026-10-08
00724995364243AMSCOAMSCO 700 Steam SterilizerEJ12213410012026-10-08
00724995364250AMSCOAMSCO 700 Steam SterilizerEJ13201100012026-10-08
00724995364267AMSCOAMSCO 700 Steam SterilizerEJ13201400012026-10-08
00724995364274AMSCOAMSCO 700 Steam SterilizerEJ13213400012026-10-08
00724995364281AMSCOAMSCO 700 Steam SterilizerEJ112022100112026-10-08
00724995364298AMSCOAMSCO 700 Steam SterilizerEJ112014000112026-10-08
00724995364304AMSCOAMSCO 700 Steam SterilizerEJ112024100112026-10-08
00724995364311AMSCOAMSCO 700 Steam SterilizerEJ112014100112026-10-08
00724995364328AMSCOAMSCO 700 Steam SterilizerEJ122011000112026-10-08
00724995364335AMSCOAMSCO 700 Steam SterilizerEJ122014000112026-10-08
00724995364342AMSCOAMSCO 700 Steam SterilizerEJ122024100112026-10-08
00724995364359AMSCOAMSCO 700 Steam SterilizerEJ122014100112026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350109400281NASteris Mexico, S. de R.L. de C.V.PEC2022-10-26
07350109400298NASteris Mexico, S. de R.L. de C.V.PEC2022-10-26