HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER

GUDID B099280078190

HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Endoscopic electrosurgical handpiece/electrode, monopolar, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable Rigid endoscopic tissue manipulation forceps, reusable
Primary Device IDB099280078190
NIH Device Record Key62e72e6d-d2ff-4f00-9b73-7c751e6b7697
Commercial Distribution StatusIn Commercial Distribution
Brand NameHEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER
Version Model Number2800-7819
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

Device Dimensions

Length24.2 Centimeter
Length24.2 Centimeter
Length24.2 Centimeter
Length24.2 Centimeter
Length24.2 Centimeter
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter
Device Size Text, specify0
Length24.2 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100192896007185 [Primary]
HIBCCB099280078190 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


[B099280078190]

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 TUNGSTEN CARBIDE DEBAKEY GRASPER ]

B09928007819S0HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER
B099280078190HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER
B09928007819L0HEARTLINE TUNGSTEN CARBIDE DEBAKEY GRASPER

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