HEARTLINE DEBAKEY GRASPER

GUDID B09928003410

HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: B09928003410
• NIH Device Record Key: e5993cfa-90be-41c7-8e54-8af5cc7f737b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEARTLINE DEBAKEY GRASPER
• Version Model Number: 2800-341
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 24.1 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007123 [Primary]
HIBCC	B09928003410 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152400

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928003410]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-24
• Device Publish Date: 2018-08-22

On-Brand Devices [HEARTLINE DEBAKEY GRASPER]

• 00192896045712: HEARTLINE DEBAKEY GRASPER STRAIGHT TIP
• B099280078270: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B099280078240: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B099280078230: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B099280078220: HEARTLINE DEBAKEY GRASPER CURVED TO SIDE 1x2 JAW
• B09928007821S0: HEARTLINE DEBAKEY GRASPER 1x2 CURVED UP JAW
• B099280078210: HEARTLINE DEBAKEY GRASPER 1x2 CURVED UP JAW
• B09928007820S0: HEARTLINE DEBAKEY GRASPER 1x2 STRAIGHT JAW
• B09928007820L0: HEARTLINE DEBAKEY GRASPER 1x2 STRAIGHT JAW
• B099280078200: HEARTLINE DEBAKEY GRASPER 1x2 STRAIGHT JAW
• B0992800341S0: HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE
• B09928003410: HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE
• B0992800340S0: HEARTLINE DEBAKEY GRASPER 1x2 JAW SQUEEZE HANDLE
• B09928003400: HEARTLINE DEBAKEY GRASPER SQUEEZE HANDLE
• B09928007827S0: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B09928007827L0: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B09928007824S0: HEARTLINE DEBAKEY GRASPER STRAIGHT
• B09928007824L0: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B09928007823S0: HEARTLINE DEBAKEY GRASPER 1X2 JAW STRAIGHT
• B09928007823L0: HEARTLINE DEBAKEY GRASPER STRAIGHT 1X2 JAW STRAIGHT
• B09928007822S0: HEARTLINE DEBAKEY GRASPER CURVED TO SIDE 1x2 JAW
• B09928007822L0: HEARTLINE DEBAKEY GRASPER CURVED TO SIDE 1x2 JAW
• B09928007821L0: HEARTLINE DEBAKEY GRASPER 1x2 CURVED UP JAW
• B0992800341L0: HEARTLINE DEBAKEY GRASPER 2x3 JAW SQUEEZE HANDLE
• B0992800340L0: HEARTLINE DEBAKEY GRASPER 1X2 JAW SQUEEZE HANDLE
• 00192896114579: Heartline Debakey Grasper Straight 1.5 x 23 Millimeter Jaw
• 00192896117655: Heartline Debakey Grasper 2.8 x 15 Millimeter Jaw Squeeze Handle