DEVICE: HEARTLINE MINI KNOT PUSHER FORCEPS (B09928004060)
Device Identifier (DI) Information
HEARTLINE MINI KNOT PUSHER FORCEPS
2800-406
Not in Commercial Distribution
SONTEC INSTRUMENTS, INC.
2800-406
Not in Commercial Distribution
SONTEC INSTRUMENTS, INC.
HEARTLINE MINI KNOT PUSHER FORCEPS HOOK & WEDGE 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? |
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45716 | Suture knot pusher, reusable |
A hand-held manual surgical instrument that enables the user performing an internal suturing procedure (e.g., suturing a heart valve in the thoracic cavity) to advance suture knots created extracorporeally to the point of appropriate suture tension. It is a long, thin, rod-like device that has a guiding mechanism (e.g., an eyelet or groove) at its distal end, allowing it to be steered down one end of the suture as it pushes the knot with its blunted nose. Saline may be used to lubricate the suture and the knot pusher if necessary. This is a reusable device.
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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 [?] |
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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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Length: 23.4 Centimeter |
Device Size Text, specify: 3mm Diameter Shaft |
Device Record Status
72a17cb6-96f4-4791-861b-c66820d0c1e7
September 24, 2018
7
August 19, 2016
September 24, 2018
7
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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