ScoutPro Slitter Tool Advanced 356552

GUDID 04035479097158

BIOTRONIK SE & Co. KG

Intravascular catheter slitter Intravascular catheter slitter
Primary Device ID04035479097158
NIH Device Record Key4106685b-056b-43bb-b41b-f906c2ecdd18
Commercial Distribution StatusIn Commercial Distribution
Brand NameScoutPro Slitter Tool Advanced
Version Model Number356552
Catalog Number356552
Company DUNS315620229
Company NameBIOTRONIK SE & Co. KG
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com
Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS104035479097158 [Primary]
GS104035479097158 [Primary]

FDA Product Code

DQXWIRE, GUIDE, CATHETER
DQXWIRE, GUIDE, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-19
Device Publish Date2014-08-27

Devices Manufactured by BIOTRONIK SE & Co. KG

04035479168773 - Home Monitoring Service Center2020-05-21
04035479097158 - ScoutPro Slitter Tool Advanced2020-05-19
04035479097158 - ScoutPro Slitter Tool Advanced2020-05-19
04035479169862 - BIOMONITOR2020-05-14
04035479158453 - BIOMONITOR2020-05-07
04035479116651 - Selectra2020-02-06
04035479116668 - Selectra2020-02-06
04035479116675 - Selectra2020-02-06
04035479116682 - Selectra2020-02-06

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