FDA.reportPublic FDA data

NA

Primary DI
07350109400281
Brand
NA
Company
Steris Mexico, S. de R.L. de C.V.
Model
15990-22
Catalog number
1599022
Device description
The ALUS Table, Domestic (6STU, 39IN, 990M) 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
07350109400281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350109400281073501094002817350109400281

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
00724995179168AMSCOAMSCO 600 Steam SterilizerEF11024322021-04-02
00724995179298AMSCOAMSCO 600 Steam SterilizerEF12023102021-04-02
00724995197414AMSCOAMSCO 600 Steam SterilizerEF1202442001022021-04-02
00724995223274AMSCOAMSCO 600 Steam SterilizerEF110232023-02-13
07350109400298NA15990-2315990232022-10-26
07350109400304NA15990-2415990242022-10-26
00724995196455AMSCOAMSCO 600 Steam SterilizerEF1102410001012021-09-27
00724995196462AMSCOAMSCO 600 Steam SterilizerEF1102310001012021-09-27
00724995196493AMSCOAMSCO 600 Steam SterilizerEF1102422001012021-09-27
00724995196509AMSCOAMSCO 600 Steam SterilizerEF1102322001012021-09-27
00724995196530AMSCOAMSCO 600 Steam SterilizerEF1102432001012021-09-27
00724995196547AMSCOAMSCO 600 Steam SterilizerEF1102332001012021-09-27
00724995196578AMSCOAMSCO 600 Steam SterilizerEF1102440001012021-09-27
00724995196585AMSCOAMSCO 600 Steam SterilizerEF1102340001012021-09-27
00724995196615AMSCOAMSCO 600 Steam SterilizerEF1102442001012021-09-27
00724995196622AMSCOAMSCO 600 Steam SterilizerEF1102342001012021-09-27
00724995196639AMSCOAMSCO 600 Steam SterilizerEF1201210001012021-09-27
00724995196646AMSCOAMSCO 600 Steam SterilizerEF1201110001012021-09-27
00724995196653AMSCOAMSCO 600 Steam SterilizerEF1202410001012021-09-27
00724995196660AMSCOAMSCO 600 Steam SterilizerEF1202310001012021-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350109400298NASteris Mexico, S. de R.L. de C.V.PEC2022-10-26
07350109400304NASteris Mexico, S. de R.L. de C.V.PEC2022-10-26