V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP

GUDID B09921008211R0

V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP WITH RATCHET STRONG CURVED

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B09921008211R0
• NIH Device Record Key: 97b8197a-db9f-47e7-8876-e6348c764ba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.T.S. SLIDER HARKEN DEBAKEY CLAMP
• Version Model Number: 2100-8211R
• 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: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• 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	00192896003583 [Primary]
HIBCC	B09921008211R0 [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

[B09921008211R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921008211R0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09921008211R0]

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: 2018-08-28

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