DEVICE: Catapult Guide Sheath (04251244502119)
Device Identifier (DI) Information
Catapult Guide Sheath
6F, 45cm, LIMA, hydrophilic coated
In Commercial Distribution
US-36045-F-LIMA-H
Contract Medical International GmbH
6F, 45cm, LIMA, hydrophilic coated
In Commercial Distribution
US-36045-F-LIMA-H
Contract Medical International GmbH
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. Introducer Sheath is hydrophilic coated on the distal end.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
Yes | |
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 |
DRE | Dilator, Vessel, For Percutaneous Catheterization |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep dry, Keep away from direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
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Length: 45 Centimeter |
Catheter Inner Diameter: 2.25 Millimeter |
Device Record Status
7e348566-6420-48ed-b8e4-6371bfb43f2c
March 20, 2024
2
September 01, 2023
March 20, 2024
2
September 01, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14251244502116 | 5 | 04251244502119 | In Commercial Distribution | Packer | |
24251244502113 | 1 | 14251244502116 | In Commercial Distribution | Corrugate |
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
[?]
+493512138888
hmdd.regulatory@heraeus.com
hmdd.regulatory@heraeus.com