FDA.reportPublic FDA data

MARK3

Primary DI
D7966125CS1
Brand
MARK3
Company
CARGUS INTERNATIONAL, INC
Model
6125CS
Device description
"Sterilization Indicator Tape 1/2"" 60 Yards 76/cs. - MARK3"
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171823000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171823000U&U Indicator tape and stripU&U Medical Technology Co, Ltd.2018-02-22JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D7966125CS1PrimaryHIBCC0
D7966125Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry place.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
096191093
Device count
76
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850014374983MARK3®597259722026-02-05
00850014374990MARK3®597459742026-02-05
00850014374648MARK3863-014C863-014C2025-10-16
00850014374655MARK3837-018XC837-018XC2025-10-16
D79690931MARK3909390932022-03-25
D79690901MARK390902017-04-14
D79690911MARK390912017-04-14
D79690921MARK390922017-04-14
D79641251MARK3412541252022-05-27
D79641261MARK3412641262022-05-27
D79653701MARK3537053702022-05-19
D79690031MARK390032025-03-06
D7969003MARK390032025-03-06
D79690011MARK390012025-02-28
D7969001MARK390012025-02-28
D7966127CS1MARK36127CS2021-04-22
D7966129CS1MARK36129CS2021-04-23
D79661270MARK361272021-04-23
D79661290MARK361292021-04-23
D79661250MARK361252021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
107073877931703M™ Attest™3M COMPANYJOJ2026-04-26
10705037015979Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-18
10705037015924Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015948Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015955Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015962Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015917Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-16
10686864061233AssureCheck™TERRAGENE S.A.JOJ2025-10-16
10686864061240AssureCheck™TERRAGENE S.A.JOJ2025-10-16
10724995245525Rapicide PA Test StripsMEDIVATORS INC.JOJ2025-06-10
07798375772815VERISURE™TERRAGENE S.A.JOJ2025-06-03
07798375772853SEALSURE™TERRAGENE S.A.JOJ2025-06-03
10615375013516MetriCide METREX RESEARCH, LLCJOJ2025-03-21
10686864061165Medicom SafeSealAMD Medicom IncJOJ2025-03-20
07798375772730VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772747VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772792VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772624BIOTRACE™TERRAGENE S.A.JOJ2024-11-12
07798375772839VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772891VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772952VERISURE™TERRAGENE S.A.JOJ2024-11-12
10724995229549CelerityALBERT BROWNE LIMITEDJOJ2024-04-22
10724995229495VERIFYALBERT BROWNE LIMITEDJOJ2024-04-08
07798375772259VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772266VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772280VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772297VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772303SEALSURE™TERRAGENE S.A.JOJ2023-11-13
07798375772327BIOTRACE™TERRAGENE S.A.JOJ2023-11-13
10724995217362Revital-OxALBERT BROWNE LIMITEDJOJ2023-08-31