V.A.T.S. FOERSTER DEBAKEY CLAMP

GUDID B099210082450

V.A.T.S. FOERSTER DEBAKEY CLAMP WITH RATCHET OVAL CURVED LEFT

SONTEC INSTRUMENTS, INC.

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

• Primary Device ID: B099210082450
• NIH Device Record Key: 2b1839e9-8309-49d8-9758-ab0f0adac699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.T.S. FOERSTER DEBAKEY CLAMP
• Version Model Number: 2100-8245
• 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: 15 Inch
• Length: 15 Inch
• Length: 15 Inch
• Length: 15 Inch
• Length: 15 Inch
• Length: 15 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896003699 [Primary]
HIBCC	B099210082450 [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

[B099210082450]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099210082450]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B099210082450]

Moist Heat or Steam Sterilization;Dry Heat 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: 2018-08-29

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