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
04251244502119
GS1

1
330926895 *Terms of Use
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. Introducer Sheath is hydrophilic coated on the distal end.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DYB Introducer, Catheter
DRE Dilator, Vessel, For Percutaneous Catheterization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry, Keep away from direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Length: 45 Centimeter
Catheter Inner Diameter: 2.25 Millimeter
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Device Record Status

7e348566-6420-48ed-b8e4-6371bfb43f2c
March 20, 2024
2
September 01, 2023
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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
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+493512138888
hmdd.regulatory@heraeus.com
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