Getinge Pack Self-Seal Pouch 61301606722

GUDID 10850144008007

Self-Seal Pouch 9cm x 25cm

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use
Primary Device ID10850144008007
NIH Device Record Key4ffb9650-fd70-4a18-add0-eaacb4dfef03
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Pack Self-Seal Pouch
Version Model NumberGUKP0925
Catalog Number61301606722
Company DUNS565751992
Company NamePMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
Device Count200
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone419-693-5307
Emailrdean@lexamed.com

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850144008000 [Primary]
GS110850144008007 [Package]
Contains: 00850144008000
Package: CASE [25 Units]
In Commercial Distribution
GS130850144008001 [Unit of Use]

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 Number5
Public Version Date2019-11-08
Device Publish Date2017-08-29

On-Brand Devices [Getinge Pack Self-Seal Pouch]

00850144008079Self-Seal Pouch 33cm x 46cm
00850144008062Self-Seal Pouch 30cm x 45cm
10850144008052Self-Seal Pouch 25cm x 38cm
00850144008048Self-Seal Pouch 20cm x 41cm
10850144008038Self-Seal Pouch 15cm x 30cm
10850144008021Self-Seal Pouch 13cm x 38cm
10850144008014Self-Seal Pouch 10cm x 28cm
10850144008007Self-Seal Pouch 9cm x 25cm

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