SET Rotarex®S 8F 110 cm (Straub Medical®) 80239

GUDID 07640142810605

The Catheter Set includes one Rotarex®S catheter (gauge 8F; length 110 cm), one guidewire (0.018” diameter; 270cm in length), one drape and one collecting bag.

Straub Medical AG

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Primary Device ID07640142810605
NIH Device Record Keyd740848e-4173-414f-9d75-6d8e1efaac4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSET Rotarex®S 8F 110 cm (Straub Medical®)
Version Model NumberVersion 1.0
Catalog Number80239
Company DUNS488489766
Company NameStraub Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com

Device Dimensions

Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French
Catheter Working Length110 Centimeter
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142810605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

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