HEARTLINE KNOT PUSHER FORCEPS

GUDID B0992800405S0

HEARTLINE KNOT PUSHER FORCEPS HOOK & WEDGE SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

Suture knot pusher, reusable Suture knot pusher, reusable Suture knot pusher, reusable

• Primary Device ID: B0992800405S0
• NIH Device Record Key: 8b514a0d-b4e5-4f75-8daf-b64c12f59bb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEARTLINE KNOT PUSHER FORCEPS
• Version Model Number: 2800-405S
• 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: 18.5 Centimeter
• Length: 18.5 Centimeter
• Length: 18.5 Centimeter
• Length: 18.5 Centimeter
• Length: 18.5 Centimeter
• Length: 18.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896007154 [Primary]
HIBCC	B0992800405S0 [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

[B0992800405S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992800405S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B0992800405S0]

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 KNOT PUSHER FORCEPS]

• B0992800405L0: HEARTLINE KNOT PUSHER FORCEPS HOOK & WEDGE SQUEEZE HANDLE
• B0992800405S0: HEARTLINE KNOT PUSHER FORCEPS HOOK & WEDGE SQUEEZE HANDLE
• B09928004050: HEARTLINE KNOT PUSHER FORCEPS HOOK & WEDGE SQUEEZE HANDLE