FDA.reportPublic FDA data

trophon Chemical Indicator

Primary DI
09350855000177
Brand
trophon Chemical Indicator
Company
NANOSONICS LIMITED
Model
N05003
Device description
Chemical Indicator
Published
2018-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
K103126000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103126000TROPHON CHEMICAL INDICATORNanosonics Limited2011-03-03JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09350855000177PrimaryGS10
09350855000399Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09350855000177093508550001779350855000177
09350855000399093508550003999350855000399

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
741021943
Device count
300
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
09350855000580CORIS QUANTUM Cleaning AgentN055032026-05-20
09350855000818CORIS Device EngineN055162026-05-20
09350855000832CORIS Adaptor O1N055172026-05-20
09350855000849CORIS Smart Drain Adaptor OAN055212026-05-20
09350855000856CORIS Smart DrainN055202026-05-20
09350855000863CORIS Maintenance KitN055222026-05-20
09350855000887CORIS Flushing AccessoryN055282026-05-20
09350855000894CORIS Smart Seal AN055232026-05-20
09350855000900CORIS Smart Seal BN055242026-05-20
09350855000993CORIS Device BodyN055152026-05-20
09350855001037trophon2 RefurbishedN05000-1R2025-11-01
09350855000740trophon3N05035-US2025-08-14
09350855000146trophon Sonex-HLN05002N05002-12PK2018-06-15
09350855000542trophon Chemical IndicatorN05003N050032022-05-12
09350855000047Trophon Chemical IndicatorN000912016-09-21
09350855000054Trophon Chemical IndicatorN00091-NNA2016-09-21
09350855000573trophon Wireless Ultrasound Probe HolderN05030-USN05030-US2024-10-25
09350855000009Trophon EPRN00010-US2016-09-21
09350855000016Trophon EPRN00010-NNA2016-09-21
09350855000122Trophon EPRN00010-US-RFB2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10665973032860DUKALDukal LLCJOJ2026-06-01
10665973032877DUKALDukal LLCJOJ2026-06-01
10665973032884DUKALDukal LLCJOJ2026-06-01
D771603531Dental CityICP, INC.JOJ2026-05-27
D771604231Dental CityICP, INC.JOJ2026-05-27
D771604251Dental CityICP, INC.JOJ2026-05-27
D771604271Dental CityICP, INC.JOJ2026-05-27
D771604281Dental CityICP, INC.JOJ2026-05-27
D771604291Dental CityICP, INC.JOJ2026-05-27
D771604391Dental CityICP, INC.JOJ2026-05-27
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