Getinge Pack Self-Seal Pouch 61301606726

GUDID 10850144008038

Self-Seal Pouch 15cm x 30cm

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use
Primary Device ID10850144008038
NIH Device Record Key46ed03c9-d1d7-44ac-a01d-0a973c85dbd7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Pack Self-Seal Pouch
Version Model NumberGUKP1530
Catalog Number61301606726
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

Phone4196935300
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
GS100850144008031 [Primary]
GS110850144008038 [Package]
Contains: 00850144008031
Package: case [14 Units]
In Commercial Distribution
GS120850144008035 [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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