FDA.reportPublic FDA data

SteriTec Cross-Checks EO

Primary DI
40814434020071
Brand
SteriTec Cross-Checks EO
Company
STERITEC PRODUCT MFG. CO., INC.
Model
CI 106
Catalog number
CI 106, CI 106/ITL
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814434020070PackageGS1250In Commercial Distribution
20814434020077PackageGS124In Commercial Distribution
30814434020074PackageGS1250In Commercial Distribution
40814434020071PackageGS124In Commercial Distribution
00814434020073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081443402007010814434020070
2081443402007720814434020077
3081443402007430814434020074
4081443402007140814434020071
00814434020073008144340200738144340200730814434020073

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
Handling Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
622223196
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814434021230Getinge Assured MI Steam Migrating Integrator Strip613016068252020-07-17
00814434020264Getinge Assured Mini Bowie-Dick Test Pack61301606667613016066672016-09-23
00814434020172"SteriTec 3/4"" Green Tape"CI 159/.75, CI 165/.75CI 159/.75, CI 165/.752016-09-23
00814434020424Getinge Assure Green Tape 3/4 IN61301606668613016066682016-09-23
00814434020448Getinge Assure Green Tape 1 IN61301606669613016066692016-09-23
00814434020004SteriTec Cross-Checks DCI 105CI 1052016-09-23
00814434020011SteriTec Steri-Pak LF Bowie-Dick Test PackBD 111BD 1112016-09-23
00814434020028SteriTec Green Card Bowie-Dick TestBD 115BD 115, BD 115/1202016-09-23
00814434020066SteriTec IntegraphCI 101CI 101, CI 101/BR, CI 101/ITL2016-09-23
00814434020073SteriTec Cross-Checks EOCI 106CI 106, CI 106/ITL2016-09-23
00814434020080SteriTec Cross-Checks CI 107/USCI 107/US2016-09-23
00814434020097SteriTec Cross-Checks SCI 134/USCI 134/US2016-09-23
00814434020110SteriTec Sterilization TapeCI 122/.5, CI 164/.5CI 122/.5, CI 164/.52016-09-23
00814434020127SteriTec Sterilization TapeCI 122/.75, CI 164/.75CI 122/.75, CI 164/.752016-09-23
00814434020134SteriTec Sterilization TapeCI 122/1, CI 164/1CI 122/1, CI 164/12016-09-23
00814434020141SteriTec Sterilization Tape - BlueCI 123/1CI 123/12016-09-23
00814434020196SteriTec Steam Integrator X 2CI 143CI 1432016-09-23
00814434020202SteriTec Emu-Graph 4CI 144CI 1442016-09-23
00814434020219SteriTec Instant Readout Chemical Integrator Challenge PackLT 101LT 1012016-09-23
00814434020226SteriTec Chemical Indicator Test Pack for Extended Timing CyclesLT 105LT 1052016-09-23

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Primary DI, Brand, Company table
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