DEVICE: HEARTLINE COOLEY SCISSORS (B09928002350)

Device Identifier (DI) Information

HEARTLINE COOLEY SCISSORS
2800-235
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09928002350
HIBCC
September 22, 2018
1
040729840 *Terms of Use
HEARTLINE COOLEY SCISSORS CURVED BLADE BLUNT TIP SQUEEZE HANDLE
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Vascular scissors A hand-held surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. It comprises two pivoted blades typically with a finger and thumb ring-handle and which cut with a shearing action. It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades are often pointed to penetrate the vessel wall and may be straight, curved sideways, or acutely angled. Some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, General & Plastic Surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152400 000
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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: 30° Blade
Device Size Text, specify: 5mm Shaft
Length: 24.2 Centimeter
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Device Record Status

e7015acf-4c27-4520-a3b7-8cd87758bfa4
August 23, 2018
6
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)

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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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