Sterilucent™ Sterilant Disc

Primary DI
00850012210030
Brand
Sterilucent™ Sterilant Disc
Company
STERILUCENT, INC.
Model
SL001
Catalog number
SL001, SL279
Published
2020-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
K140464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140464000STERILUCENT PSD-85 HYDROGEN PEROXIDE STERILIZERSterilucent, Inc.2014-10-31MLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012210030PackageGS15In Commercial Distribution
00850012210047PackageGS15In Commercial Distribution
00850012210023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012210030008500122100308500122100300850012210030
00850012210047008500122100478500122100470850012210047
00850012210023008500122100238500122100230850012210023

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogen peroxide device sterilantA gaseous or liquid substance that includes hydrogen peroxide (H2O2) as its primary agent to completely destroy or eliminate all harmful microorganisms on a medical device (e.g., surgical or dental instrument). The medical device is typically bathed by the substance for a specified period of time in order to achieve sterilization. The substance may be presented in discrete quantities to accommodate the requirements of a sterilization device or system. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005634969
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850012210009Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120VHC 80TT-120-001HC 80TT-120-0012020-04-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800066500306STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
08800066500320STERILINK™Plasmapp Co.,Ltd.MLR2023-07-13
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00889024636613Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636675Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636682Trilogy®Zimmer, Inc.MLR2022-02-25
00889024636699Trilogy®Zimmer, Inc.MLR2022-02-25
00850012210023Sterilucent™ Sterilant DiscSTERILUCENT, INC.MLR2020-04-29