Getinge Pack Self-Seal Sterilization Pouch 33cm x 46cm 6005500050

GUDID 20814434020701

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging, single-use Sterilization packaging, single-use
Primary Device ID20814434020701
NIH Device Record Keye7d258d9-20ae-424e-a244-74bfe8d20ebc
Commercial Distribution Discontinuation2016-09-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGetinge Pack Self-Seal Sterilization Pouch 33cm x 46cm
Version Model Number6005500050
Catalog Number6005500050
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
GS100814434020707 [Primary]
GS110814434020704 [Package]
Contains: 00814434020707
Package: Bag [200 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS120814434020701 [Package]
Contains: 10814434020704
Package: Case [1 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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