Getinge Pack Self-Seal Sterilization Pouch 25cm x 38cm 6005500048

GUDID 20814434020688

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging, single-use
Primary Device ID20814434020688
NIH Device Record Key74c91d63-3966-448b-9dcf-6a08d5bea8db
Commercial Distribution Discontinuation2016-09-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGetinge Pack Self-Seal Sterilization Pouch 25cm x 38cm
Version Model Number6005500048
Catalog Number6005500048
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 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020684 [Primary]
GS110814434020681 [Package]
Contains: 00814434020684
Package: Bag [200 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS120814434020688 [Package]
Contains: 10814434020681
Package: Case [3 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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