DEVICE: INT (06950900922350)

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Device Record History
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Device Identifier (DI) Information
INT
YCK119B
In Commercial Distribution

Shanghai Kindly Medical Instruments Co., Ltd.
06950900922350
GS1

1
420827639 *Terms of Use
Push-click Y connector, torque device, insertion tool;
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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?
65480 Vascular guidewire introduction sleeve
A noninvasive tubular device designed to be connected to the proximal (external) end of an in situ vascular introducer or guide catheter, and inserted beyond the pre-opened haemostatic valve, to facilitate introduction of a vascular guidewire. It is intended to channel the guidewire to prevent bending/kinking as forward pressure is applied. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K170024 000
No CLOSE

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
6d18383e-06b6-43fb-a929-88db75fabb9e
August 22, 2023
1
August 14, 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
16950900922357 25 06950900922350 In Commercial Distribution box
56950900922355 100 06950900922350 In Commercial Distribution carton
26950900922354 50 06950900922350 In Commercial Distribution box
46950900922358 200 06950900922350 In Commercial Distribution carton
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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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