FDA.reportPublic FDA data

MTS300 Cabinet, Steris, Standard

Primary DI
00851489007017
Brand
MTS300 Cabinet, Steris, Standard
Company
Stericube, LLC
Model
MTS300 Cabinet STR-0
Catalog number
MTS300 Cabinet STR-0
Device description
MTS 300 Sterilization Cabinet, Steris Standard
Published
2016-12-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152014000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152014000MTS300 Multiple Tray Sterilization SystemPmbs, LLC2015-10-20KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851489007017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851489007017008514890070178514890070170851489007017

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
908-300-7093mem.pmbs@gmail.com

Regulatory Flags#

DUNS number
079665067
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851489007215MTS225 TCFL Transfer CartMTS-225-TC-TCFLMTS-225-TC2020-06-01
00851489007055MTS300 Cabinet,MTS300 Cabinet SteriCUBE-300-CAB2016-12-09
00851489007109MTS300 Transfer CartMTS300 Transfer CartSteriCUBE-300-CART2017-01-24
00851489007222SteriCUBE Filter Kit +SteriCUBE-PACK-025-FCSKITMTS-25-FCSKIT2024-01-22
00851489007253SteriCUBECERAMIC DISC KIT031001-002026-01-06
00851489007239SteriCUBE 225 Cabinet, STERIS 600MTS225-STR-1 CABSteriCUBE-CBNT-225-ST06002024-01-22
00851489007246SteriCUBE 225 Transfer Cart, STERIS 600MTS225-STR-1 TCSteriCUBE-CART-225-ST06002024-01-22
00851489007185MTS225 STERIS Transfer CartMTS-225-TC-STR-1MTS-225-TC-STR-12020-06-01
00851489007192MTS225 GETINGE CabinetMTS-225-CAB-GET-1MTS-225-CAB-GET-12020-06-01
00851489007208MTS225 GETINGE Transfer CartMTS-225-TC-GET-1MTS-225-TC-GET-12020-06-01
00851489007000MTS300 Filter KitMTS300-FiltersMTS-Filters2016-12-09
00851489007024MTS300 Transfer Cart, Steris, StandardMTS300 Transfer Cart STR-0MTS300 Transfer Cart STR-02016-12-09
00851489007031MTS300 Cabinet, Steris, StandardMTS300 Cabinet STR-1RMTS300 Cabinet STR-1R2016-12-09
00851489007048MTS300 Transfer Cart, Steris, StandardMTS300 Transfer Cart STR-1RMTS300 Transfer Cart STR-1R2016-12-09
00851489007062MTS300 Transfer Cart, Steris, StandardMTS300 Transfer Cart STR-1MTS300 Transfer Cart STR-12016-12-09
00851489007079MTS300 Cabinet, Steris, EvolutionMTS300 Cabinet STR-2SteriCUBE-CBNT-300-STEVOL2016-12-09
00851489007086MTS300 Transfer Cart, Steris, EvolutionMTS300 Transfer Cart STR-2SteriCUBE-CART-300-STEVOL2016-12-09
00851489007093MTS300 Floor Loader, GetingeMTS300 Floor Loader GET-FLMTS300 Floor Loader GET-FL2017-01-24
00851489007116MTS300 Transfer Cart, GetingeMTS300 Transfer Cart, GET-1MTS300 Transfer Cart, GET-12017-01-24
00851489007123MTS300 Cabinet, GetingeMTS300 Cabinet GET-1MTS300 Cabinet GET-12017-07-25

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