FDA.reportPublic FDA data

"SteriTec 1"" Green Tape"

Primary DI
00814434020189
Brand
"SteriTec 1"" Green Tape"
Company
STERITEC PRODUCT MFG. CO., INC.
Model
CI 159/1, CI 165/1
Catalog number
CI 159/1, CI 165/1
Published
2016-09-23
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122555000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122555000STERITEC LEAD FREE STERILIZATION PROCESS INDICATOR TAPESteritec Products Mfg Co, Inc.2012-12-12JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814434020186PackageGS136In Commercial Distribution
20814434020183PackageGS136In Commercial Distribution
30814434020180PackageGS19In Commercial Distribution
40814434020187PackageGS14In Commercial Distribution
00814434020189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081443402018610814434020186
2081443402018320814434020183
3081443402018030814434020180
4081443402018740814434020187
00814434020189008144340201898144340201890814434020189

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging tapeA non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius38 Degrees Celsius

Regulatory Flags#

DUNS number
622223196
Device count
1
Lot or batch
true
Expiration date on label
true

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201831JMUJMU DENTAL, INCJOJ2026-06-05
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00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
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00840456202951JMUJMU DENTAL, INCJOJ2026-06-05
00840456202968JMUJMU DENTAL, INCJOJ2026-06-05
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00840456202982JMUJMU DENTAL, INCJOJ2026-06-05
00840456202999JMUJMU DENTAL, INCJOJ2026-06-05
00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
00840456207215JMUJMU DENTAL, INCJOJ2026-06-05
00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
00840456215197JMUJMU DENTAL, INCJOJ2026-06-05
00840456215203JMUJMU DENTAL, INCJOJ2026-06-05