V.A.T.S. Slider Harken Debakey Clamp 2100-8211

GUDID 00192896115521

V.A.T.S. Slider Harken Debakey Clamp Without Ratchet Strong Curve 1x2 Teeth

SONTEC INSTRUMENTS, INC.

Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable Surgical soft-tissue manipulation forceps, scissors-like, reusable

• Primary Device ID: 00192896115521
• NIH Device Record Key: fbbfa62c-5edd-4638-b5ce-d0ec6fb66147
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.T.S. Slider Harken Debakey Clamp
• Version Model Number: 2100-8211
• Catalog Number: 2100-8211
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch
• Length: 14 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896115521 [Primary]

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

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896115521]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-27
• Device Publish Date: 2023-09-19

On-Brand Devices [V.A.T.S. Slider Harken Debakey Clamp]

• B09921008211R0: V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP WITH RATCHET STRONG CURVED
• 00192896115521: V.A.T.S. Slider Harken Debakey Clamp Without Ratchet Strong Curve 1x2 Teeth