DEVICE: HEARTLINE COOLEY SCISSORS (B0992800230L0)
Device Identifier (DI) Information
HEARTLINE COOLEY SCISSORS
2800-230L
Not in Commercial Distribution
SONTEC INSTRUMENTS, INC.
2800-230L
Not in Commercial Distribution
SONTEC INSTRUMENTS, INC.
HEARTLINE COOLEY SCISSORS CURVED BLADE SQUEEZE HANDLE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
44354 | Vascular scissors |
A hand-held, manual 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. Often referred to as micro-scissors, it is a metallic device with two small pivoted blades which cut with a shearing action. The blades are often pointed to penetrate the vessel wall, may be straight, curved sideways, or acutely angled, and may include carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCJ | Laparoscope, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152400 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 15° Blade |
Device Size Text, specify: 5mm Diameter Shaft |
Device Record Status
fc7c5009-3523-4ae9-a21a-66a0c0dea121
December 21, 2018
8
August 19, 2016
December 21, 2018
8
August 19, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-821-7496
info@sontecinstruments.com
info@sontecinstruments.com