FDA.reportPublic FDA data

VERIFY SixCess

Primary DI
10724995088955
Brand
VERIFY SixCess
Company
STERIS CORPORATION
Model
LCC003
Catalog number
LCC003
Device description
The VERIFY SixCess 270F 4 Challenge Packs are used to monitor steam sterilization loads and can be used to release non implant loads.
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
K070895000
K073683000
K162758000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070895000VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK; 275F 3 CHALLENGE PACK; 275F 10 CHALLENGE PACKSTERIS Corporation2007-09-05JOJ
K073683000VERIFY CHALLENGE PACKS - VERSION 2STERIS Corporation2008-01-25JOJ
K162758000VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge PackSTERIS Corporation2017-03-21JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995088955PrimaryGS10
00724995088958Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499508895510724995088955
00724995088958007249950889587249950889580724995088958

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, Specify00Keep away from direct light
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
961394798
Device count
20
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995234232V. MuellerCD14BCD14B2026-08-26
00724995234249V. MuellerCD14BBLACKCD14BBLACK2026-08-26
00724995234256V. MuellerCD14BBLUECD14BBLUE2026-08-26
00724995234263V. MuellerCD14BGOLDCD14BGOLD2026-08-26
00724995234270V. MuellerCD14BGREENCD14BGREEN2026-08-26
00724995234287V. MuellerCD14BPURPLECD14BPURPLE2026-08-26
00724995234294V. MuellerCD14BREDCD14BRED2026-08-26
00724995234300V. MuellerCD14CCD14C2026-08-26
00724995234317V. MuellerCD14CBLACKCD14CBLACK2026-08-26
00724995234324V. MuellerCD14CBLUECD14CBLUE2026-08-26
00724995234331V. MuellerCD14CGOLDCD14CGOLD2026-08-26
00724995234348V. MuellerCD14CGREENCD14CGREEN2026-08-26
00724995234355V. MuellerCD14CPURPLECD14CPURPLE2026-08-26
00724995234362V. MuellerCD14CREDCD14CRED2026-08-26
00724995234379V. MuellerCD15BCD15B2026-08-26
00724995234386V. MuellerCD15BBLACKCD15BBLACK2026-08-26
00724995234393V. MuellerCD15BBLUECD15BBLUE2026-08-26
00724995234409V. MuellerCD15BGOLDCD15BGOLD2026-08-26
00724995234416V. MuellerCD15BGREENCD15BGREEN2026-08-26
00724995234423V. MuellerCD15BPURPLECD15BPURPLE2026-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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