FDA.reportPublic FDA data

NA

Primary DI
00724995176730
Brand
NA
Company
Corporation Steris Canada
Model
FD257
Catalog number
FD257
Device description
The RAS 12 Long Rack is designed to enable the mechanical cleaning, rinsing, and disinfection of up to 12 robotic-assisted surgery instruments in the AMSCO 7052HP and or 7053HP Single Chamber Washer Disinfectors.
Published
2019-09-09
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
NVEWasher, cleaner, automated, endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NVEWasher, Cleaner, Automated, EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190081000RAS 12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO 7052HP/7053HP Single Chamber Washer/DisinfectorSTERIS Corporation2019-08-21NVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995176730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995176730007249951767307249951767300724995176730

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
202659140
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995094119NAC1201EC1201E2020-09-25
00724995094126NAC1221EC1221E2020-09-25
00724995094133NAC1141EC1141E2020-09-25
00724995090753NAC1202EC1202E2020-06-29
00724995090777NAC1222EC1222E2020-06-29
00724995090791NAC1142EC1142E2020-06-29
00724995090739NAC1160EC1160E2020-01-02
00724995090746NAC1200EC1200E2020-01-02
00724995090760NAC1220EC1220E2020-01-02
00724995090784NAC1140EC1140E2020-01-02
00724995157449NAC3000XLC3000XL2020-01-02
00724995170554SYSTEM 1 endo1 endoP69002019-10-04
00724995092986SYSTEM 1E Liquid Chemical Sterilant Processing System1E65002016-09-13
00724995196042AMSCO5052FH14042S0012020-09-04
00724995216504NAReliance 6000 ConnectorsRECT1CON7P2026-01-14
00724995151416NAMB000010MB0000102016-09-13
00724995151423NAMB000015MB0000152016-09-13
00724995194420NAFlow Unit 11EPSC011INT2020-04-30
00724995001544NAFlow Unit 8EPSC008INT2016-09-13
00724995001551NAFlow Unit 9EPSC009INT2016-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00677964072970Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089039Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089091Medivators HookupMEDIVATORS INC.NVE2024-04-01
00677964089046Medivators HookupMEDIVATORS INC.NVE2023-10-16
00677964033070Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064210Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064227Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064258Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064296Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064302Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064326Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064333Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064340Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064357Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064364Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964064371Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085222Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085246Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085253Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085260Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085277Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085284Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964085291Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088957Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088964Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088971Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088988Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964088995Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089008Medivators HookupMEDIVATORS INC.NVE2023-04-10
00677964089015Medivators HookupMEDIVATORS INC.NVE2023-04-10