FDA.reportPublic FDA data

SteriScan

Primary DI
00724995152246
Brand
SteriScan
Company
STERIS CORPORATION
Model
3305NC
Catalog number
3305NC
Device description
The SteriScan Reusable Test Pack without counter and with 200 Steam Sterilization Integrators.
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K102761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102761000DANA REUSABLE TEST PACK FOR STEAM STERILIZATIONDana Products, Inc.2010-12-20JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995152246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995152246007249951522467249951522460724995152246

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store near heat source.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
040469731
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10665973032860DUKALDukal LLCJOJ2026-06-01
10665973032877DUKALDukal LLCJOJ2026-06-01
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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
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10615375013516MetriCide METREX RESEARCH, LLCJOJ2025-03-21
10686864061165Medicom SafeSealAMD Medicom IncJOJ2025-03-20
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07798375772839VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772891VERISURE™TERRAGENE S.A.JOJ2024-11-12