FDA.reportPublic FDA data

MTS300 Filter Kit

Primary DI
00851489007000
Brand
MTS300 Filter Kit
Company
Stericube, LLC
Model
MTS300-Filters
Catalog number
MTS-Filters
Device description
Filter Kit for SteriCUBE Cabinets
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
Single use
true

Contact Domains#

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
00851489007000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851489007000008514890070008514890070000851489007000

GMDN Terms#

Term, Definition table
TermDefinition
Sterility label/tagA label or tag designed for use prior to, during, and after the process of sterilization of the device it has been attached to for the purpose of indicating that the sterility level required has been achieved. This label/tag can be designed with various built-in indicators that show if the sterility level has been reached or not, e.g., a change in the colour of the label/tag. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
908-300-7093mem.pmbs@gmail.com
8334112823info@stericubeinc.com

Regulatory Flags#

DUNS number
079665067
Device count
1
Lot or batch
true
Expiration date on label
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
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
00851489007147STERIS BridgeMTS-BR-STRMTS-BR-STR2020-06-01

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