Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle SL291

GUDID 00850012210078

STERILUCENT, INC.

Biological sterilization indicator
Primary Device ID00850012210078
NIH Device Record Key3711cb71-a485-46dc-9273-e7951ee92d84
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle
Version Model NumberSL291
Catalog NumberSL291
Company DUNS005634969
Company NameSTERILUCENT, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-721-8405
EmailCustomerService@Sterilucent.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *• 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850012210078 [Unit of Use]
GS100850012210085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-07
Device Publish Date2020-04-29

Devices Manufactured by STERILUCENT, INC.

00850012210030 - Sterilucent™ Sterilant Disc2020-05-07
00850012210054 - Sterilucent™ Process Challenge Device PCD-L for HC 80TT Lumen Cycle2020-05-07
00850012210078 - Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle2020-05-07
00850012210078 - Sterilucent™ Process Challenge Device PCD-F for HC 80TT Flexible Cycle2020-05-07
00850012210009 - Sterilucent™ HC 80TT Hydrogen Peroxide Sterilizer 120V2020-05-06

Trademark Results [Sterilucent]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STERILUCENT
STERILUCENT
77824014 4238030 Live/Registered
Sterilucent, Inc.
2009-09-10

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