Biotronik Fortress Introducer Sheath System 444483

GUDID 14251244500587

Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator.

Contract Medical International GmbH

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Primary Device ID14251244500587
NIH Device Record Key8bb06cef-738b-4c85-aad8-c371b60ca3c9
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronik Fortress Introducer Sheath System
Version Model Number90 cm, 5F Straight
Catalog Number444483
Company DUNS330926895
Company NameContract Medical International GmbH
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+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com
Phone+410448645111
Emailinfo.vi@biotronik.com

Device Dimensions

Length90 Centimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter
Lumen/Inner Diameter1.95 Millimeter
Length90 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS104251244500580 [Primary]
GS114251244500587 [Package]
Contains: 04251244500580
Package: Packer [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-07
Device Publish Date2018-11-30

On-Brand Devices [Biotronik Fortress Introducer Sheath System]

14251244500600Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500594Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500587Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500570Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500563Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
04251244500559Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500099Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500082Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
14251244500075Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500068Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500051Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
14251244500044Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1)
14251244500037Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
04251244500023Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)
14251244500013Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2)

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