Getinge Pack Self-Seal Sterilization Pouch 13cm x 38cm 6005500044

GUDID 20814434020640

STERITEC PRODUCT MFG. CO., INC.

Sterilization packaging, single-use
Primary Device ID20814434020640
NIH Device Record Key3a1f8849-e913-45d0-bd13-06b2d791aeca
Commercial Distribution Discontinuation2016-09-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGetinge Pack Self-Seal Sterilization Pouch 13cm x 38cm
Version Model Number6005500044
Catalog Number6005500044
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
GS100814434020646 [Primary]
GS110814434020643 [Package]
Contains: 00814434020646
Package: Bag [200 Units]
Discontinued: 2016-09-23
Not in Commercial Distribution
GS120814434020640 [Package]
Contains: 10814434020643
Package: Case [6 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

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

10814434020803 - SteriTec Green Tape 3/4"2022-06-17
10814434021312 - SteriTec Green Tape 1"2022-06-17
10814434021633 - Getinge Assured Green Tape 3/4"2022-06-17
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.