DEVICE: Biotronik Fortress Introducer Sheath System (04251244500016)
Device Identifier (DI) Information
Biotronik Fortress Introducer Sheath System
45 cm, 4F Straight
In Commercial Distribution
358814
Contract Medical International GmbH
45 cm, 4F Straight
In Commercial Distribution
358814
Contract Medical International GmbH
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58865 | Vascular catheter introduction set, nonimplantable |
A 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DYB | Introducer, Catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K100799 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Keep away from direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 1.62 Millimeter |
Length: 45 Centimeter |
Device Record Status
9f0fd72b-2841-43a5-8b6c-c19db77e5ea8
March 20, 2024
6
June 30, 2016
March 20, 2024
6
June 30, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14251244500013 | 5 | 04251244500016 | In Commercial Distribution | Packer |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+410448645111
info.vi@biotronik.com
info.vi@biotronik.com