DEVICE: CARDIOPLEGIA NEEDLE (B099280074930)

Device Identifier (DI) Information

CARDIOPLEGIA NEEDLE
2800-7493
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B099280074930
HIBCC
September 22, 2018
1
040729840 *Terms of Use
HEARTLINE CARDIOPLEGIA NEEDLE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
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
Pericardiocentesis needle, reusable A sharp bevel-edged, hollow tubular metal instrument specifically designed for the puncture of the pericardial cavity for the aspiration (removal) of fluids (pericardiocentesis). The device is typically long and rigid enough to penetrate the pericardium (e.g., 10 to 18 centimetres in length). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GDM Needle, Aspiration And Injection, Reusable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: 3.5mm 12 1/2"
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Device Record Status

9695dedc-b41d-46c4-bbd7-547cd1c49799
September 07, 2018
5
August 19, 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
No Package DIs found
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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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
800-821-7496
info@sontecinstruments.com
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