HEARTLINE COLVIN NEEDLE HOLDER

GUDID B0992800042S0

HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

Needle holder, reusable Needle holder, reusable Needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable
Primary Device IDB0992800042S0
NIH Device Record Key9223eed8-3752-4397-b06a-806cf3d3fd8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEARTLINE COLVIN NEEDLE HOLDER
Version Model Number2800-042S
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
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com
Phone800-821-7496
Emailinfo@sontecinstruments.com

Device Dimensions

Length17.8 Centimeter
Length17.8 Centimeter
Length17.8 Centimeter
Length17.8 Centimeter
Length17.8 Centimeter
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter
Length17.8 Centimeter
Device Size Text, specify0
Device Size Text, specify0
Length17.8 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896079632 [Primary]
HIBCCB0992800042S0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[B0992800042S0]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B0992800042S0]

Dry Heat Sterilization;Moist Heat or Steam 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 COLVIN NEEDLE HOLDER]

B0992800042S0HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE
B09928000400HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT SQUEEZE HANDLE
B09928000420HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE
B0992800042L0HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE CURVED JAW SQUEEZE HANDLE
B0992800040S0HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT JAW SQUEEZE HANDLE
B0992800040L0HEARTLINE COLVIN NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE STRAIGHT SQUEEZE HANDLE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.