Getinge Pack Self-Seal Pouch 61301606723

GUDID 10850144008014

Self-Seal Pouch 10cm x 28cm

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use
Primary Device ID10850144008014
NIH Device Record Key7d31d123-1936-40b3-9e8d-698abfd6572a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Pack Self-Seal Pouch
Version Model NumberGUKP1028
Catalog Number61301606723
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.net

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850144008017 [Primary]
GS110850144008014 [Package]
Contains: 00850144008017
Package: Case [15 Units]
In Commercial Distribution
GS120850144008011 [Unit of Use]

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 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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