DEVICE: Super Sheath Introducer Sheath (04543527199735)

Device Identifier (DI) Information

Super Sheath Introducer Sheath
(S-3N5/0895)BT33Z05PPW018
In Commercial Distribution

TOGO MEDIKIT CO.,LTD.
04543527199735
GS1

1
690724240 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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, 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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FDA Product Code

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Product Code Product Code Name
DYB INTRODUCER, CATHETER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K121504 000
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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
Special Storage Condition, Specify: Store in a dry, dark, cool place.
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 5cm Length
Device Size Text, specify: 3.3Fr Sheath size
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Device Record Status

c5ec7468-dc88-44da-8c9e-88c4e95627f3
July 06, 2018
3
September 16, 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
74543527199734 45 14543527199732 In Commercial Distribution Carton
14543527199732 5 04543527199735 In Commercial Distribution Box
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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)

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

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Yes
No
Yes
No
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Customer Contact

[?]
No Customer Contact currently defined
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