Getinge Pack Self-Seal Sterilization Pouch 9cm x 13cm 6005500041

GUDID 20814434020619

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging, single-use Sterilization packaging, single-use
Primary Device ID20814434020619
NIH Device Record Key488ef9e5-c073-4d3b-bef5-a3e5d7f45d84
Commercial Distribution Discontinuation2016-09-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGetinge Pack Self-Seal Sterilization Pouch 9cm x 13cm
Version Model Number6005500041
Catalog Number6005500041
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 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020615 [Primary]
GS110814434020612 [Package]
Contains: 00814434020615
Package: Bag [200 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS120814434020619 [Package]
Contains: 10814434020612
Package: Case [30 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, Sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-23

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