FDA.reportPublic FDA data

NA

Primary DI
00724995176723
Brand
NA
Company
Corporation Steris Canada
Model
FD256
Catalog number
FD256
Device description
The RAS 12 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
00724995176723PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995176723007249951767237249951767230724995176723

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

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Primary DI, Brand, Company table
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00677964089015Medivators HookupMEDIVATORS INC.NVE2023-04-10