FDA.reportPublic FDA data

Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle

Primary DI
00850012210061
Brand
Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle
Company
STERILUCENT, INC.
Model
SL290
Catalog number
SL290
Published
2020-04-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850012210061PrimaryGS10
00850012210054Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850012210061008500122100618500122100610850012210061
00850012210054008500122100548500122100540850012210054

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

Contacts#

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

Regulatory Flags#

DUNS number
005634969
Device count
25
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

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

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