FDA.reportPublic FDA data

STERIDENT

Primary DI
B234FRGDHIS400635
Brand
STERIDENT
Company
CPAC EQUIPMENT, INC.
Model
400635
Device description
"DRY HEAT INDICATOR STRIPS 4"", 100/BOX"
Published
2018-09-20
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B234FRGDHIS400635PrimaryHIBCC0

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
601985976
Device count
1
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
B234KMHRHPRO111230V1RH-Pro11-230VRH-PRo11-230V2020-10-01
B234KMHRHPRO9115V3RH-Pro9RH-Pro92020-10-01
B234KMHRHPRO9115V4RH-Pro9-230VRH-Pro9-230V2020-10-01
B234FRGSSNP400636STERIDENT4006362018-08-31
B234FRGSSNP400637STERIDENT4006372018-08-31
B234FRGSSNP400638STERIDENT4006382018-08-31
B234FRGSSNP400639STERIDENT4006392018-08-31
B234FRGSSNP400651STERIDENT4006512018-08-31
B234JCXPD101008115PORTODENT1010082018-08-31
B234JCXPD101009230PORTODENT1010092018-08-31
B234JCXPD101125115PORTODENT1011252018-08-31
B234KMHCX6000115V150COX RAPIDHEAT6000COX-115V-152018-07-31
B234KMHCX6000115V161COX RAPIDHEAT6000-16COX-115V-162018-08-23
B234KMHCX6220230V152COX RAPIDHEAT6220COX-230V-152018-08-24
B234KMHCX6220230V163COX RAPIDHEAT6220COX-230V-162018-08-24
B234KMHRHPRO111115V0RH-Pro11RH-Pro112019-01-18
B234KMHSD201000115STERIDENT2002018-08-31
B234KMHSD201000230STERIDENT2002018-08-31
B234KMHSD301000115STERIDENT3002018-08-31
B234KMHSD301000230STERIDENT3002018-08-31

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