Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V

Primary DI
00850012210009
Brand
Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V
Company
STERILUCENT, INC.
Model
HC 80TT-120-001
Catalog number
HC 80TT-120-001
Published
2020-04-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLRSterilizer, Chemical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLRSterilizer, ChemicalGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190005000Sterilucent HC 80TT Hydrogen Peroxide SterilizerSterilucent, Inc.2019-09-13MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012210009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012210009008500122100098500122100090850012210009

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide gas sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using hydrogen peroxide (H2O2) gas with low humidity content as the sterilizing agent; it is typically used for products sensitive to high temperature and humidity. It includes a treatment chamber where the devices to be sterilized are placed, usually after cleaning of gross debris, and a means to introduce the gas into the chamber; it is not intended to generate a gas plasma. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-721-8405CustomerService@Sterilucent.com

Regulatory Flags#

DUNS number
005634969
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012210023Sterilucent™ Sterilant DiscSL001SL001, SL2792020-04-29
00850012210061Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen CycleSL290SL2902020-04-29
00850012210085Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible CycleSL291SL2912020-04-29
00850012210030Sterilucent™ Sterilant DiscSL001SL001, SL2792020-04-29
00850012210054Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen CycleSL290SL2902020-04-29
00850012210078Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible CycleSL291SL2912020-04-29

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Primary DI, Brand, Company table
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08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
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00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29