FDA.reportPublic FDA data

Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle

Primary DI
00850012210078
Brand
Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle
Company
STERILUCENT, INC.
Model
SL291
Catalog number
SL291
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
FRCIndicator, Biological Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192001000Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge DeviceSterilucent, Inc.2019-10-22FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012210085PrimaryGS10
00850012210078Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012210085008500122100858500122100850850012210085
00850012210078008500122100788500122100780850012210078

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store in direct sunlight or any other form of UV light.
Special Storage Condition, Specify00• Do not store near any sterilizer; sources of ethylene oxide or hydrogen peroxide; alkalis, acids, or oxidizers; volatile antimicrobials such as glutaraldehyde or formaldehyde; and sterilant packages
Storage Environment Humidity60 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature36 Degrees Fahrenheit77 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
25
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
00850012210030Sterilucent™ Sterilant DiscSL001SL001, SL2792020-04-29
00850012210054Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen CycleSL290SL2902020-04-29

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Primary DI, Brand, Company table
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307073878129123M™ Attest™3M COMPANYFRC2026-04-10
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307073878129433M™ Attest™3M COMPANYFRC2026-04-10
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