FDA.reportPublic FDA data

Biotronik Fortress Introducer Sheath System

Primary DI
04251244500030
Brand
Biotronik Fortress Introducer Sheath System
Company
Contract Medical International GmbH
Model
45 cm, 4F Crossover
Catalog number
358813
Device description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
Published
2016-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100799000FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815Contract Medical Intl. GmbH2011-02-25DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251244500037PackageGS15In Commercial Distribution
04251244500030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450003714251244500037
04251244500030042512445000304251244500030

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length45Centimeter
Lumen/Inner Diameter1.62Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+410448645111info.vi@biotronik.com

Regulatory Flags#

DUNS number
330926895
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251244502768Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
04251244502775Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
04251244502782Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
14251244502765Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
14251244502772Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
14251244502789Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
04251244503604Biotronik Fortress Introducer Sheath System4F; 45 cm; straight3588142024-06-24
04251244503611Biotronik Fortress Introducer Sheath System4F; 100 cm; straight358815 2024-06-24
04251244503628Biotronik Fortress Introducer Sheath System4F; 45 cm; crossover358813 2024-06-24
04251244503635Biotronik Fortress Introducer Sheath System4F; 65 cm; straight444486 2024-06-24
04251244503642Biotronik Fortress Introducer Sheath System4F; 90 cm; straight4444852024-06-24
04251244503659Biotronik Fortress Introducer Sheath System5F; 45 cm; straight386591 2024-06-24
04251244503666Biotronik Fortress Introducer Sheath System5F; 100 cm; straight386592 2024-06-24
04251244503673Biotronik Fortress Introducer Sheath System5F; 45 cm; crossover3865902024-06-24
04251244503680Biotronik Fortress Introducer Sheath System5F; 65 cm; straight444484 2024-06-24
04251244503697Biotronik Fortress Introducer Sheath System5F; 90 cm; straight444483 2024-06-24
04251244503703Biotronik Fortress Introducer Sheath System6F; 45 cm; straight386594 2024-06-24
04251244503710Biotronik Fortress Introducer Sheath System6F; 100 cm; straight386595 2024-06-24
04251244503727Biotronik Fortress Introducer Sheath System6F; 45 cm; crossover386593 2024-06-24
04251244503734Biotronik Fortress Introducer Sheath System6F; 65 cm; straight444482 2024-06-24

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H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
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