HEARTLINE RYDER NEEDLE HOLDER

GUDID B09928000300

HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE

SONTEC INSTRUMENTS, INC.

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• Primary Device ID: B09928000300
• NIH Device Record Key: b17d0a36-3a3a-4e04-b94c-a7973ac9fa0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEARTLINE RYDER NEEDLE HOLDER
• Version Model Number: 2800-030
• 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
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• Phone: 800-821-7496
• Email: info@sontecinstruments.com
• 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: 23.5 Centimeter
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter
• Length: 23.5 Centimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 23.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896006829 [Primary]
HIBCC	B09928000300 [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

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

[B09928000300]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09928000300]

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 RYDER NEEDLE HOLDER]

• B09928000300: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE DUST STRAIGHT JAW SQUEEZE HANDLE
• B09928000210: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE SHAFT SQUEEZE HANDLE
• B0992800020S0: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE JAW SQUEEZE HANDLE
• B09928000200: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE JAW SQUEEZE HANDLE
• B0992800021S0: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE JAW SQUEEZE HANDLE
• B0992800021L0: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE SHAFT SQUEEZE HANDLE
• B0992800020L0: HEARTLINE RYDER NEEDLE HOLDER WITH LOCK TUNGSTEN CARBIDE JAW SQUEEZE HANDLE