HEARTLINE STATIC KNOT PUSHER

GUDID B09928004100

HEARTLINE STATIC KNOT PUSHER WITH COMPOSITE HANDLE

SONTEC INSTRUMENTS, INC.

Suture knot pusher, reusable
Primary Device IDB09928004100
NIH Device Record Key458d37f9-8c0a-4187-b777-5b9c13301d8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEARTLINE STATIC KNOT PUSHER
Version Model Number2800-410
Company DUNS040729840
Company NameSONTEC INSTRUMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length13 Inch
Length13 Inch
Length13 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896007178 [Primary]
HIBCCB09928004100 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B09928004100]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B09928004100]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B09928004100]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-24
Device Publish Date2018-08-22

On-Brand Devices [HEARTLINE STATIC KNOT PUSHER]

B09928004100HEARTLINE STATIC KNOT PUSHER WITH COMPOSITE HANDLE
00192896121508Heartline Static Knot Pusher Titanium Handle

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.