Getinge Pack Sterilization Roll 61301606745

GUDID 00850144008215

Sterilization Roll 5cm x 30m

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use
Primary Device ID00850144008215
NIH Device Record Key4fad58d2-6796-4fc8-9dd2-85c410bde315
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Pack Sterilization Roll
Version Model NumberGUFL0530
Catalog Number61301606745
Company DUNS565751992
Company NamePMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI
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 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
GS100850144008215 [Primary]
GS110850144008212 [Package]
Package: Case [12 Units]
In Commercial Distribution

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 Date2017-12-17

On-Brand Devices [Getinge Pack Sterilization Roll]

00850144008345Sterilization Roll 30cm x 30m
00850144008321Sterilization Roll 23cm x 30m
00850144008291Sterilization Roll 15cm x 30m
10850144008267Sterilization Roll 10cm x 30m
00850144008246Sterilization Roll 7.5cm x 30m
00850144008215Sterilization Roll 5cm x 30m

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