DEVICE: Biotronik Fortress Introducer Sheath System (04251244500030)

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Device Identifier (DI) Information

Biotronik Fortress Introducer Sheath System
45 cm, 4F Crossover
358813
Contract Medical International GmbH
04251244500030
GS1
1
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular catheter introduction set A collection of sterile, 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.
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FDA Product Code

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Product Code Product Code Name
DYB Introducer, Catheter
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 1.62 Millimeter
Length: 45 Centimeter
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Device Status

In Commercial Distribution
June 30, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
14251244500037 5 04251244500030 In Commercial Distribution Packer
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+410448645111
info.vi@biotronik.com
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