V.A.T.S. HARKEN DEBAKEY CLAMP

GUDID B0992100820R0

V.A.T.S. HARKEN DEBAKEY CLAMP WITH RATCHET MEDIUM CURVED

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B0992100820R0
• NIH Device Record Key: a265f561-90d8-4516-b8bd-d154122b6bf9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.T.S. HARKEN DEBAKEY CLAMP
• Version Model Number: 2100-820R
• 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

Device Dimensions

• 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	00192896010512 [Primary]
HIBCC	B0992100820R0 [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

[B0992100820R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992100820R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992100820R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-21
• Device Publish Date: 2018-08-24

On-Brand Devices [V.A.T.S. HARKEN DEBAKEY CLAMP]

• B0992100820R0: V.A.T.S. HARKEN DEBAKEY CLAMP WITH RATCHET MEDIUM CURVED
• B0992100821R0: V.A.T.S. HARKEN DEBAKEY CLAMP WITH RATCHET FULL CURVED JAW
• B09921008210: V.A.T.S. HARKEN DEBAKEY CLAMP WITHOUT RATCHET FULL CURVED
• B09921008200: V.A.T.S. HARKEN DEBAKEY CLAMP WITHOUT RATCHET MEDIUM CURVED