Heartline Knot Pusher

GUDID 00192896111295

Heartline Knot Pusher Squeeze Handle

SONTEC INSTRUMENTS, INC.

Suture knot pusher, reusable

• Primary Device ID: 00192896111295
• NIH Device Record Key: 0f459000-84a8-4032-941a-9517a7a7f896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartline Knot Pusher
• Version Model Number: 2800-407
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com
• Phone: +1(800)821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896111295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002877

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[00192896111295]

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: 2021-09-20
• Device Publish Date: 2021-09-10

On-Brand Devices [Heartline Knot Pusher]

• 00192896111295: Heartline Knot Pusher Squeeze Handle
• 00192896113015: Heartline Knot Pusher Forceps - Push To Open Shaft Squeeze Handle