SteriTec 3/4" Green Tape CI 159/.75, CI 165/.75

GUDID 10814434020179

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging tape
Primary Device ID10814434020179
NIH Device Record Key9d8f362a-619d-4e8e-9d48-decfed17c254
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec 3/4" Green Tape
Version Model NumberCI 159/.75, CI 165/.75
Catalog NumberCI 159/.75, CI 165/.75
Company DUNS622223196
Company NameSTERITEC PRODUCT MFG. CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020172 [Primary]
GS110814434020179 [Package]
Contains: 00814434020172
Package: Case [48 Units]
In Commercial Distribution
GS120814434020176 [Package]
Contains: 00814434020172
Package: Case [48 Units]
In Commercial Distribution
GS130814434020173 [Package]
Contains: 00814434020172
Package: Sleeve [12 Units]
In Commercial Distribution
GS140814434020170 [Package]
Contains: 30814434020173
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-23
Device Publish Date2016-09-23

Devices Manufactured by STERITEC PRODUCT MFG. CO., INC.

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10814434021640 - Getinge Assured Green Tape 1"2022-06-17
30814434021231 - Getinge Assured MI Steam Migrating Integrator Strip2020-07-27
10732224109265 - Crosstex International2020-05-06 Sure Check Strip
20814434020619 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm2019-11-08
20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm2019-11-08

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