SteriTec 1" Green Tape CI 159/1, CI 165/1

GUDID 10814434020186

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging tape
Primary Device ID10814434020186
NIH Device Record Key419a2349-dd0a-4e95-b06f-2e1842358d42
Commercial Distribution StatusIn Commercial Distribution
Brand NameSteriTec 1" Green Tape
Version Model NumberCI 159/1, CI 165/1
Catalog NumberCI 159/1, CI 165/1
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 TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 38 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020189 [Primary]
GS110814434020186 [Package]
Contains: 00814434020189
Package: Case [36 Units]
In Commercial Distribution
GS120814434020183 [Package]
Contains: 00814434020189
Package: Case [36 Units]
In Commercial Distribution
GS130814434020180 [Package]
Contains: 00814434020189
Package: Sleeve [9 Units]
In Commercial Distribution
GS140814434020187 [Package]
Contains: 30814434020180
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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20814434020626 - Getinge Pack Self-Seal Sterilization Pouch 9cm x 23cm2019-11-08

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