HEARTLINE JAMESON TENOTOMY SCISSORS

GUDID B09928007831S0

HEARTLINE JAMESON TENOTOMY SCISSORS CURVED BLADE SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

Vascular scissors Vascular scissors Vascular scissors

• Primary Device ID: B09928007831S0
• NIH Device Record Key: 120aed39-0ee6-406b-94e1-7eb16d1104f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEARTLINE JAMESON TENOTOMY SCISSORS
• Version Model Number: 2800-7831S
• 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: 19.1 Centimeter
• Length: 19.1 Centimeter
• Length: 19.1 Centimeter
• Length: 19.1 Centimeter
• Length: 19.1 Centimeter
• Length: 19.1 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896010901 [Primary]
HIBCC	B09928007831S0 [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

[B09928007831S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928007831S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928007831S0]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-08-24

On-Brand Devices [HEARTLINE JAMESON TENOTOMY SCISSORS]

• B09928007831S0: HEARTLINE JAMESON TENOTOMY SCISSORS CURVED BLADE SQUEEZE HANDLE
• B099280078310: HEARTLINE JAMESON TENOTOMY SCISSORS CURVED BLADE SQUEEZE HANDLE
• B09928007831L0: HEARTLINE JAMESON TENOTOMY SCISSORS CURVED BLADE SQUEEZE HANDLE