Getinge Pack Sterilization Pouch 61301606763

GUDID 00850144008710

Sterilization Pouch 40cm x 40cm

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use
Primary Device ID00850144008710
NIH Device Record Key0c582eae-c678-499f-87a8-1765d57ec5c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Pack Sterilization Pouch
Version Model NumberGUFP4040
Catalog Number61301606763
Company DUNS565751992
Company NamePMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
Device Count250
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
GS100850144008710 [Primary]
GS100850144008727 [Package]
Package: Case [4 Units]
In Commercial Distribution
GS100850144008734 [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 Date2018-01-20

On-Brand Devices [Getinge Pack Sterilization Pouch]

00850144008710Sterilization Pouch 40cm x 40cm
00850144008680Sterilization Pouch 30cm x 45cm
00850144008659Sterilization Pouch 30cm x 30cm
00850144008628Sterilization Pouch 25cm x 38cm
00850144008598Sterilization Pouch 20cm x 40cm
00850144008567Sterilization Pouch 20cm x 25cm
00850144008543Sterilization Pouch 20cm x 33cm
00850144008512Sterilization Pouch 15cm x 25cm
00850144008482Sterilization Pouch 13cm x 38cm
00850144008468Sterilization Pouch 10cm x 56cm
00850144008437Sterilization Pouch 10cm x 30cm
00850144008406Sterilization Pouch 10cm x 20cm
00850144008376Sterilization Pouch 7.5cm x 20cm

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