FDA.reportPublic FDA data

NA

Primary DI
07350109400052
Brand
NA
Company
Steris Mexico, S. de R.L. de C.V.
Model
15966-02
Catalog number
1596602
Device description
The Loading Car with 2 Shelves (6STU, 39-Inch, 990 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
07350109400052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350109400052073501094000527350109400052

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.

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
05902533549597Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-10-16
00724995364168AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364175AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364182AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364199AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364205AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364212AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364229AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364236AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364243AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364250AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364267AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364274AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364281AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364298AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364304AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364311AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364328AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364335AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364342AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364359AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364366AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364373AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364380AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364397AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995364557AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
00724995368562AMSCOSteris Mexico, S. de R.L. de C.V.FLE2026-10-08
05902533549511Getinge 500 SeriesGETINGE IC PRODUCTION POLAND SP Z O OFLE2026-05-15
07629999825710EnbioEnbio Group AGFLE2026-05-12
07629999932531EnbioEnbio Group AGFLE2026-05-12