Getinge Pack Tyvek Pouch 61301606741

GUDID 00850144008178

Tyvek Pouch 20cm x 40cm

PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Sterilization packaging, single-use
Primary Device ID00850144008178
NIH Device Record Keyfc00b9ee-40bc-402d-b830-274c3974af52
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Pack Tyvek Pouch
Version Model NumberGUTP2040
Catalog Number61301606741
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
GS100850144008178 [Primary]
GS110850144008175 [Package]
Package: Case [4 Units]
In Commercial Distribution
GS120850144008172 [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 Date2017-10-01

On-Brand Devices [Getinge Pack Tyvek Pouch]

00850144008208Tyvek Pouch 30cm x 45cm
00850144008192Tyvek Pouch 25cm x 45cm
00850144008185Tyvek Pouch 25cm x 38cm
00850144008178Tyvek Pouch 20cm x 40cm
00850144008161Tyvek Pouch 20cm x 30cm
00850144008154Tyvek Pouch 15cm x 30cm
00850144008147Tyvek Pouch 10cm x 56cm
00850144008130Tyvek Pouch 10cm x 30cm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.