Heartline Needle Holder

GUDID 00192896110496

Heartline Needle Holder With Lock 1, 2 X 8, 5 Millimeter Tungsten Carbide Dust Jaw Curved Squeeze Handle

SONTEC INSTRUMENTS, INC.

Suturing needle holder, reusable

• Primary Device ID: 00192896110496
• NIH Device Record Key: 6ddda402-41a4-4995-8abb-edc87b2aa646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Heartline Needle Holder
• Version Model Number: 2800-025
• 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
• 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: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter
• Length: 18 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896110496 [Primary]

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

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[00192896110496]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-02
• Device Publish Date: 2021-06-24

On-Brand Devices [Heartline Needle Holder]

• B0992800035S0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
• B09928000350: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
• B0992800030S0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE
• B0992800035L0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST CURVED JAW SQUEEZE HANDLE
• B0992800030L0: HEARTLINE NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE
• 00192896110496: Heartline Needle Holder With Lock 1, 2 X 8, 5 Millimeter Tungsten Carbide Dust Jaw Curved Squeez